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(Editor’s Note: 3E is expanding news coverage to provide customers with insights into topics that enable a safer, more sustainable world by protecting people, safeguarding products, and helping businesses grow. Expert Analysis articles, produced by 3E subject matter experts, researchers, and consultants as well as external thought leaders, examine the regulations, trends, and forces impacting the use, manufacture, transport, and export/import of chemicals.)
South Korea has been utilizing two powerful tools, the Korean Act on the Registration and Evaluation of Chemicals (K-REACH) and the Occupational Safety and Health Act (K-OSHA) to actively regulate chemicals to protect public health and the environment. There are important dates looming in 2024 and 2025 for both K-REACH and K-OSHA.
For K-REACH, registration is due by 31 December 2024 for existing substances of 100 t/y or more. The expected implementation of registration for new chemical substances of 1 t/y or more is January 2025. For K-OSHA, material safety data sheet (MSDS) submission for existing chemical product manufacture or import between 1 ton and 10 ton is required by 16 January 2025.
Sometimes harmonious, sometimes not when it comes to chemical regulations and compliance, these two wide-reaching Acts have had and will continue to have a major impact on any company manufacturing or importing chemicals into Korea. (For a more detailed analysis of K-REACH and K-OSHA, download the article “Expert Analysis: The Impact, Importance, and Intersection of K-REACH and K-OSHA” here.
The main difference between K-REACH and K-OSHA is their areas of focus: While K-REACH focuses on the registration and evaluation of chemical substances, K-OSHA focuses on the registration of safety data sheets (SDS) and the safe use of chemicals in the workplace. Companies must understand the requirements and comply with both regulations prior to the manufacture or import of chemical substances and products to ensure they successfully navigate doing business in the Korean market.
K-REACH Regulatory Overview
Having adopted the legislative structure of the European Union’s REACH Regulation, Korea’s Ministry of Environment (MoE) implemented the Korean Act on the Registration and Evaluation of Chemicals (K-REACH) in 2015, with the aim of protecting public health and the environment from risks caused by chemical substances. The four main components of K-REACH are:
- Registration/Notification of Chemical Substances
- Priority Control Substance Notification in Chemical Products
- Hazard Evaluation and Risk Assessment of Chemical Substances
- Sharing Information of Chemical Substances
K-OSHA Regulatory Overview
In the wake of increasing chemical accidents over the years, the Ministry of Employment and Labor (MoEL) amended and implemented the Occupational Safety and Health Act (K-OSHA) with significant changes in January 2021. One of the most prominent changes includes the Material Safety Data Sheet (MSDS) registration requirement, which is unprecedented. Previously, the MSDS was communicated between upstream manufacturers and downstream users without the authority’s involvement.
Additionally, in MSDS Section 3, the claim of confidential business information (CBI) is no longer allowed. Companies that wish to conceal their business’ confidential chemicals must apply for CBI and obtain the MoEL’s approval. The key requirements under the amended K-OSHA are:
- MSDS registration (submission)
- MSDS Registration Number displayed on the first page of MSDS.
- CBI application for the authority’s approval.
- Industry to provide “substitute” name (e.g., generic name).
- CBI approval number, approved substitute name, CBI validity/expiration date to be displayed.
- Non-hazardous chemical verification
It is extremely important for companies to know that both K-REACH and K-OSHA require full compliance prior to manufacture and import. The requirements are highly complex and unique, requiring stakeholders to pay close attention in assessing their time and cost to achieve successful compliance.
Upcoming Developments
The K-REACH authorization stage has been taking shape, led by the MoE. Companies are closely monitoring the final version of the first batch of chemicals subject to authorization. However, detailed compliance procedures must be provided by the authority. Furthermore, a tonnage change of annual manufacture or import requiring new chemical substance registration has been proposed from 0.1 ton to 1 ton. Once implemented, it will considerably reduce industry’s administrative and financial burden.
Another development to watch is the effort of the two ministries, the MoE and the MoEL, to harmonize and simplify the CBI processes. There have been several notices in which the two authorities cross-reference CBI-related dossiers to reduce the to reduce the industry’s administrative burden.
Download the full article, Expert Analysis: The Impact, Importance, and Intersection of K-REACH and K-OSHA: What You Need to Know, here to learn more about the full requirements and impact of K-REACH and K-OSHA.
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About the author: Kristyn Hong, Associate Director – Asia Pacific, 3E Regulatory Research, oversees the team of regulatory analysts who are responsible for regulatory management, research, and analysis, and is also responsible for researching, analyzing, and monitoring overall chemical and other EH&S related governmental legislations and regulations in Asia Pacific region. With nearly 25 years of regulatory and international trade compliance experience, she has presented at many international conferences where she is widely recognized as an expert in the EH&S, chemical risk management, and regulatory landscape. As a Korean regulatory expert, she has been a signature speaker on K-REACH, K-BPR, CCA (Chemical Control Act), and K-OSHA in major chemical conferences and assisting chemical industry to make best compliance practices and business decisions.
Contributor: Sandy Smith, Senior Reporter, 3E, is an award-winning newspaper reporter and business-to-business journalist who has spent 20+ years researching and writing about EHS, regulatory compliance and risk management and networking with EHS professionals. She is passionate about helping to build and maintain safe workplaces and promote workplace cultures that support EHS. She has presented at major conferences and has been interviewed about workplace safety and risk by The Wall Street Journal, CNN and USA Today.
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