The National Institute of Environmental Research (NIER) in South Korea plans to evaluate biocidal products for the approval of biocidal substance and biocidal products under the Consumer Chemical Products and Biocides Safety Control Act (K-BPR). Regarding this evaluation, an update on test methods for determining the shelf life of biocidal products was provided on April 12th, 2023.
Applicants for the approval must submit complete physical and chemical stability test data proving that the quality (content, effect, efficacy, etc.) of the biocidal product is stable during the shelf life. Long-term storage test, acceleration storage test, and low-temperature stability test (liquid) are mandatory, but it can be exempted under certain conditions.
Tests |
Exempted conditions |
Long-term storage test |
|
Acceleration storage test |
|
Low-temperature stability test (liquid) |
|
New case with the stability test
• Testing Institute: Recommended to submit data produced by testing institutes that comply with international standards. Example: ISO 9001, ISO/IEC 17025, GLP, etc.
• Test data: Long-term storage test and acceleration storage test data that conform to the shelf life of biocidal products must be submitted, but test data can be selectively submitted depending on the shelf life and storage temperature & conditions.
Submitting existing test data
• Scope: Limited to products that have been approved by submitting stability test data as daily use consumer chemical product subject to safety verification and approval.
• Approval: Resubmit the stability test data that was submitted and got approval as the daily use consumer chemical product subject to safety verification and approval, and the shelf life given at the time of approval would be accepted.