Effective from January 1, 2025, the amended K-REACH regulation has raised the tonnage threshold for new chemical registrations from 0.1 t/y to 1 t/y.

This update carries significant implications for companies managing new chemical substances at low volumes. To align compliance strategies, there have been ongoing discussions with authorities concerning whether a modification application would be required if the subsequent annual volume falls between 0.1 t/y and 1 t/y.

According to official clarification, the current K-REACH does not include provisions requiring modifications for changes in annual import or manufacture quantities. Consequently, substances notified with annual volumes below 0.1 t/y before 2025 do not require any additional action. Companies may continue to manufacture or import these notified substances with annual volumes up to 1 t/y.

Additionally, for corporate reference, modification of a new chemical notification would apply under the following circumstances:

• Changes in the notified substance’s use.
• Addition of consumer uses or modifications to existing consumer uses.
• Changes in the characteristics or hazards of the notified substance that meet one of the following conditions:
  • New information about the substance’s properties or hazards results in a change to its hazard classification.
  • New information confirms the substance poses risks to human health or the environment.
• Changes in the importer of the substance (limited to cases where the OR has been appointed or the substance has been notified).
• Changes in the company commissioned to manufacture the substance (limited to South Korean companies, applicable in OEM cases).

For inquiries about product registration and market access solutions, please contact us.