South Korea notifies conditions for submission of hazard data for biocidal substances that have been evaluated internationally

The National Institute of Environmental Research (NIER) in South Korea notifies conditions for submission of hazard data for 31 biocidal substances that have been evaluated internationally. This is to maintain reliable biocide approval system by clarifying the management methods of hazard information of biocidal substances that have been evaluated internationally. This will enable efficient implementation of the biocide approval system for existing biocidal substances subject to get the approval by 2024.

Scope:

- 31 biocidal substances that have been evaluated internationally among existing biocidal substances subject to get the approval by 2024

- exclusion: 15 substances under evaluation or unable to confirm evaluation information

Conditions for data submission:

① Prioritizing the substances that completed 2^nd international evaluation: For the same biocidal substance, if the hazardous data submission condition for the first evaluation and second evaluation is different, the data submitted for the second evaluation will be prioritized.

② Additional data submission: Test data (CMR, PBT, EDCs, etc.) of major approval category (approval criteria, determination of valid date, etc.) may be required additionally during the approval evaluation to enhance the reliability of the data.

③ Submission of retained data: For the substances that completed 2^nd international evaluation, it is possible to submit retained data to enhance the reliability of the data. If it is a reliable data, the data submitted by an applicant will be prioritized (only applicable for individual submission).

④ Risk Assessment: Applicants should confirm risks index and submit risk assessment result including risk reduction plan.

⑤ Ensuring completeness: Completed data with substance manufacturer certificate (including manufacturing site), component analysis report (including impurities), representative product sample, etc should be submitted (till June 2023).