We have collected the latest FAQs on ordinarycosmetics filingfrom the Guangzhou Administration for Market Regulation and translated them into English for your reference.

1. Why does the "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics" recommend using CMCC strains?

The "Technical Guidelines for Preservative Challenge Testing and Assessment of Cosmetics" (referred to as the "Guidelines") recommending CMCC strains is primarily due to the simplicity of the purchasing process and the availability of the strains. Although ATCC strains originate from global biological resource centers, they are expensive and involve a complex purchasing process. When purchasing ATCC strains, users need to provide various documents, including a letter of commitment, application form, company profile, bio-safety certificate, product transfer agreement, and business license, and undergo Chinese customs inspection. These requirements significantly increase the difficulty for most domestic cosmetic registrants and filers, making it challenging to obtain them through legitimate channels. Additionally, the long transportation time for ATCC strains can introduce uncertainties to the testing process. In contrast, CMCC strains, as domestic standard strains, are relatively cheaper and more accessible, with a simpler purchasing process. This saves cosmetic registrants and filers significant time and cost, making them more suitable for preservative challenge testing.

2. Can cosmetic registrants and filers choose other methods for preservative challenge test evaluation?

The "Technical Guidelines" serve as a non-mandatory reference, primarily aimed at providing guidance and recommendations for cosmetic registrants and filers conducting related tests. Registrants and filers can select industry standards, international standards (such as ISO 11930), or develop their own methods to comprehensively evaluate the effectiveness of the product’s preservative system based on their actual needs and circumstances.

3. If the product uses the four neutralizers from Appendix A.6 to A.9, but validation results show that these neutralizers are still ineffective against certain strains, what methods should be employed to resolve this issue?

The four neutralizers in Appendix A.6 to A.9 are only recommended options. Cosmetic registrants and filers can select appropriate neutralizers based on the actual product formulation.

4. Can the "Technical Guidelines" include a method for mixed microbial inoculation?

Mixed microbial inoculation may lead to differences in test results compared to single-strain inoculation, increasing the complexity and uncertainty of result evaluation. Considering the consistency and repeatability of test results, and following the recommended practices of international standards, the "Technical Guidelines" do not adopt the method of mixed microbial inoculation.

5. What are the evaluation requirements for the preservative challenge test for products with the same preservative system and similar formulations?

For products with the same preservative system and similar formulations, the effectiveness of the preservative system could be evaluated by referencing existing data and experimental results. This will allow you to prepare a preservative challenge evaluation report and then submit documentation detailing the preservative and formulation systems.

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Further Information

Collection of Q&As on ordinary cosmetics filing in Guangzhou