Question 1: What is the difference between human trials and consumer use tests?
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Answer 1: The difference between human trials and consumer use tests is mainly about the environment.
My colleague has translated these 2 tests rules from a Chinese regulation for you below:
The definitions of the "Human Trial" and "Consumer Use Test" are in "Technical Guidance for Cosmetic Efficacy Claims" Article 20, (3)&(4):
My colleague has translated these 2 tests rules from a Chinese regulation for you below:
The definitions of the "Human Trial" and "Consumer Use Test" are in "Technical Guidance for Cosmetic Efficacy Claims" Article 20, (3)&(4):
"(3) Human Trial: refers to the process of making objective evaluation conclusions on product efficacy claims through subjective evaluation, objective measurement and statistical analysis of human test results in accordance with prescribed methods and procedures under laboratory conditions.
(4) Consumer Use Test: refers to the process of effectively collecting, sorting and analyzing the consumers' product usage and efficacy claim evaluation information on the basis of objective and scientific methods."
Basically, according to the Chinese regulation "Technical Guidance for Cosmetic Efficacy Claims", the "Human Trial Test" needs to happen in a lab by following certain laboratory rules and working together with volunteers.
"Consumer Use Test" is about getting data from consumers in the market, for example, by regularly giving questionnaires to the customers who have been using this product to provide feedback, collecting and analysing the data to prove your products' quality.
Question 2: Can the product labels remain in English and use the "refer to insert" symbol and have the Chinese product description printed on the leaflet? Can we use a QR code to show the product description instead of a leaflet?
Question 2: Can the product labels remain in English and use the "refer to insert" symbol and have the Chinese product description printed on the leaflet? Can we use a QR code to show the product description instead of a leaflet?
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Answer 2: I am afraid, the product labels can't remain in English and use the "refer to insert" symbol and have the Chinese product description printed on the leaflet in the Chinese market. The Chinese NMPA has very strict rules for cosmetic label details to be in Chinese characters. QR codes can not replace the Chinese language label.
Question 3: In order to be exempt from animal testing, we cannot use new ingredients that are within the safety monitoring period. What about the NEW ingredients that are not even in the safety monitoring period?
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Answer 3: The answer is no. It's very strict in China. The NMPA has a document giving the list of permitted ingredients, any ingredients that are not listed in that document will be counted as a cosmetic new ingredient. The ingredient will be put into the safety monitoring period if you use it.
Webinar e-Slide: https://newsletter.zmuni.com/books/tsph/
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ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心
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