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South Korea provides an update on test methods for determining the shelf life of biocidal products

2023-04-17 Reference source : CHEMP

Biocides Stability testing


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

  • The product is stored at room temperature, and the shelf life is less than 3 years, and the acceleration storage test has been performed

Acceleration storage test

  • The product is stored at room temperature, and there is data proving that the product is not exposed to temperatures higher than 30 ℃, and long-term storage test has been performed at room temperature
  • The product is cold storage product, and long-term storage test has been performed at set temperature

Low-temperature stability test (liquid)

  • The product labeling includes the statement that the product should not be stored below 0 ℃

 

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.



We acknowledge that the above information has been compiled from CHEMP.

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