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).

 

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

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

2

  • 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

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