South Korea Clarifies RBP Criteria and Data Requirements for Simplified Substance Approval

South Korea Clarifies RBP Criteria and Data Requirements for Simplified Substance ApprovalOn March 30, 2021, the Korean Environmental Industry & Technology Institute (KEITI) issued a guidance regarding the selection criteria and data requirements for representative biocidal products (RBP) of biocidal substances to be approved through the simplified process.

When applying for a substance approval, one or more representative biocidal product(s) corresponding to the use type of the biocidal substance need to be selected to prove the safety and efficacy. Substances that have been registered/approved in the EU or US are deemed as internationally evaluated substances and enjoy waived data requirements. Depending on the availability of data in the evaluation report or opened literature, the applicant of substance approval needs to submit 4 parts of data on representative biocidal products (RBP).




I. Product Information

Identification information


Physical, chemical, or biological properties


Classification, labeling and packaging


Component analysis information


II. Human Hazard and Risk Assessment

Hazard Identification


Dose-response assessment


Exposure assessment (exposure scenario)


Risk determination


Human risk assessment results


III. Environmental Hazard and Risk Assessment

Hazard Identification


Species sensitivity distribution evaluation


Exposure assessment (exposure scenario)


Risk determination


Results of environmental risk assessment


IV. Effectiveness and Efficacy Evaluation    

Effect and efficacy information


Limit of effect and efficacy


Effect and efficacy evaluation result


* If there is no data (test result) in the international approval report or it is not public, and it is necessary to submit it according to domestic exposure information (including use) by product type.

Representative biocidal product(s) is selected through the discussion by the joint submission council of the active substance and different criteria for application can be applied depending on the operation status. Typically, products that represent all uses, user groups and sites of the substance and products with inhalation concerns should be selected as the RBP. If not applicable, RBP can be selected according to the following priority:


  • Products being sold and distributed and largely used domestically;
  • Products with large exposure


  • Products containing a high content of biocidal substances;
  • Products with large use amount;
  • Products mainly used by general and professional users

Reference Link

South Korea Updates Biocidal Active Substances Subject to Simplified Approval

Something Wrong? At Chemlinked we do our utmost to provide you with accurate information. However sometimes errors slip under the radar, we’re only human. That’s where you our vigilant reader come in! If you notice any errors contact us on: Budding Journalist ? Send us your news on: