On 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).
| Compulsory | Conditional |
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:
1 |
|
2 |
|
Reference Link
South Korea Updates Biocidal Active Substances Subject to Simplified Approval
