On June 25, 2021, South Korea’s Environmental Industry and Technology Institute (KEITI) opened an online platform for the approval of biocidal active substances under the Act on Safety Management of Household Chemical Products and Biocidal Products (K-BPR). It was designed to receive dossier and communicate with registrants.
According to K-BPR, the existing biocidal active substances, after pre-registration or late pre-registration can be granted a grace period of up to ten years for manufacture or import prior to final approval. The active substances are classified into four groups with corresponding deadline for approval. The deadline for approval of the first group of active substances, i.e., disinfectants, algaecides, rodenticides, insecticides and repellents is December 31, 2022.
For enterprises that wish to obtain approval of the same active substance, it is necessary to establish a consortium to prepare for joint submission during the grace period. A lead registrant will submit the dossier online firstly and after notified by the authority of starting assessment, the co-registrants can submit their own dossiers. It will take up to one year for the MoE to issue a draft assessment report. Registrants can make appeals through the platform to the K-BPR committee within 30 days if they disagree with the assessment results. The committee will further review the assessment report and after that the MoE will make a final decision on approval/non-approval.
Considering the fact that the whole process staring from applying for approval until getting a final decision on approval will take a maximum of 18 months, potential registrants of the first group of active substances should join consortium and prepare dossiers as soon as possible.