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Beijing MPA Releases Q&A on Cosmetics Preservation Challenge




1 . What is the purpose of cosmetics preservation challenge test?


Cosmetic preservation challenge test refers to a test that artificially contaminates cosmetics with a certain amount of bacteria, fungi and other microorganisms under certain conditions to simulate the possible contamination of cosmetics, detect the amount of surviving bacteria at regular intervals, and evaluate the effectiveness of the cosmetics preservation system based on the change in the amount of surviving bacteria. Cosmetic preservation challenge test helps to clarify the effectiveness of cosmetics preservation system in protecting against microorganisms that may be introduced during the production, storage and use of cosmetics, and provides a guarantee for consumers to use cosmetics safely.


2 . When cosmetics registrants conduct cosmetics preservation challenge tests, must they conduct research in accordance with the "Technical Guidelines for Evaluation of Cosmetic Preservation Challenge Tests"?


Cosmetics registrants and filers can choose industry standards, international standards (such as ISO 11930) or self-built methods based on their actual needs and circumstances to conduct a comprehensive evaluation of the effectiveness of the product anti-corrosion system. The "Technical Guidelines for Evaluation of Cosmetic Preservation Challenge Tests" is a non-mandatory reference document. Cosmetic registrants and filers can refer to the "Technical Guidelines for Evaluation of Cosmetic Preservation Challenge Tests" or other methods to conduct relevant research when conducting preservation challenge tests.


3 . In addition to the "Technical Guidelines for Evaluation of Cosmetic Preservation Challenge Tests", what are the relevant standards and methods that can be referenced for cosmetic preservative challenge tests?


(1) ISO 11930-2019 Cosmetics - Microbiology - Evaluation of the antimicrobial protection of a cosmetic product

(2) AOAC 998.10-2009 Efficacy of Preservation of Non-Eye Area Water-Miscible Cosmetic and Toiletry Formulations

(3) USP 43-NF 38<51> Antimicrobial effectiveness testing

(4) "Pharmacopoeia of the People's Republic of China" (2020 Edition) Part IV General Chapter 1121 Antimicrobial Effectiveness Test Method

(5) T/SHRH 017-2019 "Cosmetic Preservation Challenge Test"

(6) T/GDCDC 010-2019 "Cosmetic Preservation Challenge Test Method"


4 . What role does the neutralizer play in the cosmetics preservation challenge test?


Neutralizer is a reagent that can be added to the mixture of cosmetics and microorganisms to eliminate the inhibitory or killing effects of antibacterial or bactericidal ingredients in cosmetics on microorganisms. It plays an important role in the cosmetics preservation challenge test. Neutralizer can avoid or reduce the potential interference of antibacterial or bactericidal ingredients in cosmetics on the test results, so that the surviving microorganisms in the cosmetics can be detected as much as possible, thereby accurately reflecting the actual contamination of microorganisms and ensuring the accuracy of the test results.


5 . How to select and use neutralizers in cosmetic preservative challenge tests?


Cosmetic registrants and recorders can choose appropriate neutralizers according to the actual product formula. Common neutralizers include SCDLP liquid culture medium, Eugon LT 100 broth, D/E neutralization broth, modified Letheen broth, etc. If the neutralization effect verification fails, you can consider replacing the neutralizer or increasing the amount of the neutralizer. When choosing to increase the amount of neutralizer, you should pay attention to gradually increase the amount of the neutralizer, and the multiple of diluting the sample with the neutralizer is recommended not to exceed 100 times.


If you have any questions related to cosmetic preservation challenge tests, please contact us via info@enter-co.com.

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