FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing (Vol. 39)

We have collected the latest FAQs on ordinary cosmetics filing from the Beijing Cosmetics Review and Inspection Center and translated them into English for your reference.

1. What is the purpose of the cosmetic preservative challenge test?

The cosmetic preservative challenge test involves deliberately contaminating cosmetics with a certain amount of bacteria and fungi under specific conditions to simulate potential contamination scenarios. The test measures the number of surviving microorganisms at regular intervals to evaluate the effectiveness of the preservative system in cosmetics. This test helps determine the protective efficacy of the preservative system against microorganisms that may be introduced during the production, storage, and use of cosmetics, ensuring consumer safety.

2. When conducting a preservative challenge test, is it mandatory for cosmetic registrants to follow the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics"?

Cosmetic registrants and filers can choose industry standards, international standards (such as ISO 11930), or self-developed methods to comprehensively evaluate the effectiveness of the product's preservative system based on their actual needs and circumstances. The "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics" is a non-mandatory reference document. Registrants and filers may refer to these guidelines or other methods when conducting preservative challenge tests.

3. Besides the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics", what other standards and methods 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) Volume IV, General Principle 1121 Antimicrobial Effectiveness Testing

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

(6) T/GDCDC 010-2019 "Cosmetic Preservative Challenge Testing Methods"

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4. What role does a neutralizer play in cosmetic preservative challenge tests?

A neutralizer is an agent that can be added to the mixture of cosmetics and microorganisms to eliminate the inhibitory or bactericidal effects of antimicrobial components in the cosmetics. It plays an important role in preservative challenge tests. Neutralizers help prevent or reduce potential interference from antimicrobial or bactericidal components in the cosmetics on the test results, allowing the surviving microorganisms to be detected as accurately as possible. This ensures the test results accurately reflect the actual microbial contamination, ensuring the accuracy of the test.

5. How should neutralizers be selected and used in cosmetic preservative challenge tests?

Cosmetic registrants or filers can choose suitable neutralizers based on the actual product formulation. Common neutralizers include SCDLP liquid medium, Eugon LT 100 broth, D/E neutralizing broth, and modified Letheen broth. If the neutralization effect is not satisfactory, consider changing the neutralizer or increasing its amount. When opting to increase the neutralizer's amount, it is advisable to do so gradually, ensuring that the dilution factor for the sample with the neutralizer does not exceed 100-fold.

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Further Information

FAQs from Beijing Cosmetics Review and Inspection Center on Ordinary Cosmetics Filing (Vol. 38)