On February 6, 2024, the Ministry of Environment of South Korea issued Order No. 20232, which includes revisions to certain parts of the K-REACH regulations.
The main changes are as follows:
- A definition for "new substances of unknown hazard classification" has been added. For these new substances, it is assumed that they are hazardous, and appropriate protective measures must be taken to ensure that they do not harm human health or the environment.
- The notification threshold for the production/import volume of new substances has been increased from 0.1 tonnes per year to 1 tonne per year. The Minister of Environment is allowed to review the accuracy of the data submitted during the declaration of new chemical substances. Anyone can provide supporting attachments to request corrections to the publicly disclosed chemical information.
| Changes in notification tonnage | Changes in required information | |
| Before January 1, 2025 | <0.1t/y | no need for hazard classification/labeling rationale |
| After January 1, 2025 | <1t/y | hazard classification/labeling rationale required (e.g., domestic and international hazard assessment reports, QSARs, literature, company data reports, etc.) |
3. In the event of a leakage of confidential data (successful CBI application), including the leakage of confidential substance information, the informant must immediately notify the Ministry of Environment of South Korea.
Effective dates:
- From January 1, 2025, the notification tonnage for new substances will change from 0.1t/y to 1t/y.
- From August 7, 2025, information about new substances will be published on the official website of the Ministry of Environment of South Korea, including:
- Substance name/CAS number
- Purity
- Molecular formula/structural formula (attachment of a search result report such as STN or ChemSpider required as identification information)
- Trade name
- Identified impurities/co-products
- Annual manufacturing/import volume
- Intended use
- Hazard classification/labeling
- Reasons for hazard classification/labeling (domestic and international hazard assessment reports, QSARs, papers, company's own data, etc.).
During the official review process, the Minister of Environment can investigate results from domestic and international reviews, assessments, and tests, and has the authority to require the notifier to provide hazardous data to confirm the substance's hazards.
This revision officially took effect on January 1, 2025, especially the change in the notification tonnage for new substances from 0.1t/y to 1t/y, which undoubtedly benefited enterprises by reducing the mandatory requirements for hazardous testing data. CIRS Group has extensive practical experience and successful cases in K-REACH new substance notifications and registration projects. If you need assistance in this area, please feel free to contact us.
Further Information
