On January 1, 2015 The Korean Toxic Chemicals Control Act (TCCA), which has been in force since 1991 and governs the manufacture, import, and general handling of regulated chemicals, was split Into two separate regulatory policies: the Act on the Registration and Evaluation of Chemicals (known as Korea REACH) and Chemicals Control Act (CCA).
K-REACH focuses on registration and evaluation of chemical substance while CCA focuses on the Control of hazardous substances and response to chemical accidents. Together the Acts will enhance Korea’s control over regulated chemicals and increase surveillance over newly introduced or manufactured substances.
Although K-Reach covers a wide range of products, it does not apply to pharmaceutical products covered under the Pharmaceuticals Affairs Act or medical devices covered under the Medical Device Act. As a result, importers of drug products and devices including investigational drugs and devices will not need to worry about K-Reach requirements.
The biggest change introduced by K-Reach is that all Korean manufacturers and importers must register their chemical substances with and submit notification to the Ministry of the Environment (MoE) prior to manufacturing or importing either of the following
• New chemical substances; or
• Existing substances (substance already listed in the TCCA) manufactured, imported or sold in quantities of more than one metric ton per year
Certain new chemicals will be exempted from K-Reach registration requirements, but these will be specifically designated by the MoE and/or by Presidential Decree. Therefore, importers of new chemical substances, such as API, not specially exempted must register their products with MoE prior to importing into Korea.
Requests for additional information on K-Reach registration and notification requirements can be directed to Marken’s Trade Compliance team via firstname.lastname@example.org.