K-REACH Compliance: Registration Deadline for Existing Chemical Substances is Getting Closer

The Act on the Registration and Evaluation of Chemicals (AREC) (known as K-REACH) is a crucial regulatory framework in South Korea aimed at ensuring the safe management of chemical substances.

Under K-REACH, manufacturers and importers of chemical substances are required to register their chemicals with the Ministry of Environment (MoE) if they exceed certain manufacture or importation volumes. One of the critical stipulations of K-REACH concerns the tonnage bands for chemical registration. Specifically, enterprises dealing with existing chemical substances within the 100-1,000 tons per year range must complete their registration by December 31, 2024.

Registration deadlines for existing chemical substances are as follows:

Key Requirements for Compliance

• Data Submission: Enterprises must submit detailed data on the chemical substances, including their properties, uses, and potential health and environmental risks. This involves gathering comprehensive information through testing and existing studies. Typically, co-registrants purchase "Letters of Access (LoA)" from the Lead Registrant (LR) under K-REACH to submit the data.
• Risk Assessment: The submission must include a risk assessment that evaluates the potential hazards associated with the chemical. This assessment will be included in the Chemical Safety Report (CSR) and should cover various aspects, such as human health impact, environmental toxicity, and potential exposure scenarios.

Steps to Ensure Timely Registration

• Early Planning: Given the complexity of the registration process, enterprises should begin planning well in advance.
• Collaboration with Experts: Engaging with regulatory consultants and experts can facilitate a smoother registration process. These professionals can provide valuable insights and assistance in preparing comprehensive and compliant dossiers.
• Estimated Time for Registration Process: Considering the time required to collect Exposure Scenario (ES) information, purchase the LoA, prepare the Chemical Safety Report (CSR), and have the authority review the registration dossier, enterprises should anticipate a timeline of approximately five months to ensure timely registration. The major factors contributing to this timeframe include:
  • Increased Registration Demand: As the registration deadline approaches, there will likely be a surge in demand for registrations, which could take approximately three months to prepare a Chemical Safety Report (CSR).
  • Extended Review Periods: The large volume of submitted dossiers may result in extended review periods by the authority.

Consequences of Non-Compliance

In case of failure to meet the December 31, 2024, deadline, manufacturers and producers will not be able to export their chemical substances to South Korea until the registration is completed. Exporting without registration can result in severe penalties, including fines.

Conclusion

The upcoming registration deadline under K-REACH for chemical substances within the 100-1,000 tonnage band is a significant milestone for foreign manufacturers and producers exporting chemical substances to South Korea. Early preparation and thorough documentation are key to successfully navigating the complexities of K-REACH.

CIRS offers Only Representative (OR) services to foreign manufacturers/producers exporting chemical substances to South Korea. As regulatory experts, we can provide smooth support for the entire K-REACH registration process.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Further Information

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