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Navigating New Chemical Registration Requirements under K-REACH Amendment

Official response to the compliance requirements for companies handling new chemical substances between 0.1 t/y and 1 t/y.

As of January 1, 2025, the revision to K-REACH has come into effect, raising the tonnage band for new chemical registration from 0.1 t/y to 1 t/y.

K-REACH

Previous 

Commence on 1 Jan 2025

New Chemical Notification

< 0.1 ty

< 1 t/y

New Chemical Registration

≥ 0.1 t/y

≥ 1 t/y 

This regulatory update has significant implications for companies handling new chemical substances at low volumes. To ensure compliance strategy, there has been ongoing communication with officials regarding whether a modification application is necessary if the subsequent annual volume falls between 0.1 t/y and 1 t/y.

Official Response

According to the official response, it is clarified that the current K-REACH does not include provisions for the modification in annual import/manufacture quantity. Therefore, companies that have notified substances below 0.1 t/y prior to 2025 are not required to take any additional actions and can manufacture/import those notified substances up to 1 t/y.

Furthermore, for corporate reference, modification in new chemical notification applies if falling under the following:

  1. A change in the use of the notified substance.

  2. Addition of consumer uses or changes to existing consumer uses of the notified substance.

  3. Changes in the characteristics or hazards of the notified substance, meeting either of the following conditions:

    1. New information regarding the substance's characteristics or hazards leads to a change in its hazard classification.

    2. New information confirms that the substance poses a harmful impact on human health or the environment;

  4. Changes in the importer of the substance (limited to those who have appointed OR notified the substance).

  5. Changes in the company commissioned to manufacture the substance (limited to companies within South Korea, applicable in the case of OEM).

ChemLinked will keep abreast of official plans to ensure our clients with the most up-to-date information and support. Please stay tuned.

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