Paraffin Oil Test Introduced by Ministry of Food and Drug Safety
Non-Clinical Test Data Using Alternative Methods to Animal Testing Now Permitted
The government will strengthen the standards for the respiratory protection performance of health masks (KF80) by adding a test to evaluate their ability to block liquid particles.
The Ministry of Food and Drug Safety announced on August 11 that it has issued an administrative notice for the revision of the "Regulations on Approval, Notification, and Review of Quasi-Drugs," which includes additional test standards for performance evaluation of quasi-drug health masks. The ministry will accept public comments until September 1.
First, in addition to the "sodium chloride test" for evaluating the blocking performance against solid particles in the dust collection efficiency test for health masks, a "paraffin oil test" for evaluating the blocking performance against liquid particles will be added. These tests are already applied to KF94 and KF99 masks, as well as European FFP1 grade masks.
The revision will also allow non-animal or human biology-based test data to be submitted for non-clinical studies on toxicity and pharmacological action when applying for quasi-drug product approval, reflecting the international trend of reducing animal testing.
The Ministry of Food and Drug Safety stated, "With this revision, we expect to strengthen mask safety management, contribute to public health improvement, and encourage the active use of alternative testing methods to animals when applying for quasi-drug product approval."
Details of the proposed revision can be found on the Ministry of Food and Drug Safety website under Legislation and Administrative Notices.
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