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K-REACH: New Chemical Regulatory Requirements to be Enforced by January 2025

Regulatory changes concerning low-volume new chemicals under K-REACH will commence on January 1, 2025. This article provides official FAQs to address industry confusion.

By Ordinance No. 20232 issued on February 6, 2024, the Korean Ministry of Environment (MoE) adopted the amendments to the K-REACH (Korean Registration, Evaluation, Authorization, and Restriction of Chemicals). Starting January 1, 2025, the annual tonnage band for new chemical registration under K-REACH will be adjusted from 0.1 t/y to 1 t/y.

K-REACH

Current

Commence on 1 Jan 2025

New Chemical Notification

< 0.1 ty

< 1 t/y

New Chemical Registration

≥ 0.1 t/y

≥ 1 t/y 

Following the new tonnage band, new chemicals manufactured or imported below 1 t/y will only be required for notification rather than registration, thereby simplified documentation requirements apply. Under K-REACH, only very simple information is required for new chemical notification, including manufacturer/importer information, chemical name and identity, uses, etc. 

However, from 2025, for new chemical notification, except for the aforementioned information, companies will be compulsively required to provide hazard classification and labeling information. The MoE shall review the submitted materials and ensure the appropriateness. Additionally, from August 7, 2025, the MoE will gradually disclose the review results to ensure the public's right to know of the hazard classification and labeling information on the new chemicals being nofitied and solicit feedback.

As the implementation date of the amendments approaches, there are still many confusions among the industry regarding the detailed compliance requirements in practice. Recently, at a seminar organized by the Korea Chemical Management Association (KCMA), officials from the Korea Environment Corporation (KECO) shared their insights into the new regulatory requirements.

Official Q&A

1. What are the implementation dates for new provisions according to K-REACH amendments?

According to the amendments, the implementation dates for major provisions are shown as below:

Implementation date

New provision

January 1, 2025

Registration tonnage band: adjust from 0.1 t/y to 1 t/y

January 1, 2025

Hazard classification and labeling information shall be provided for new chemical notification (< 1 t/y)

August 7, 2025

The review of hazard classification and labeling information on new chemicals subject to notification and the disclose of hazard review results

2. Will the compliance obligations for new chemicals notified before the effective date be affected by the regulatory changes under K-REACH?

New chemicals (< 0.1 ty) that have been notified and have obtained the notification certificates under K-REACH before 1 January 2025, the certificate will still be valid with no additional obligation. However, if the actual manufacture/import volume is between 0.1 t/y and 1 t/y, the hazard classification and labeling information may be required for submission.

3. Can ECHA's publicly available hazard classification and labeling information be used for new chemical notification? 

Existing data or information confirmed by domestic or external databases can be utilized for new chemical notification, but it shall be demonstrated that the data corresponds to the new substance being notified.

4. When disclosing the hazard classification and labeling information of new chemicals being notified, will the company information also be disclosed to the public? 

Company information will not be made public.

5. For substances whose hazards have not yet been determined, is there a preparation for preventive measures before the business confirms no hazards? When is the expected implementation date?

The related measures will be introduced by the National Institution of Chemical Safety (NICS), and made public in the future.

The K-REACH amendments will promote the gradual standardization and improvement of actual compliance steps concerning new chemical regulatory system. The MoE will comprehensively consider various situations encountered by companies in practice and provide targeted reference guidelines. ChemLinked will continue to closely follow the latest developments in Korea's new chemical regulatory system and keep abreast of official future plans, ensuring the most up-to-date information support for enterprises. Please stay tuned.

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