Since the formal implementation of CSAR, the original hair care special cosmetics are no longer categorised as cosmetics. Correspondingly, the “anti-hair loss“ special cosmetics have been added in the category. The new regulation has been implemented for nearly one year, and the new registration system has been put into use for more than half a year.
The number of registered imported “anti-hair loss“ cosmetics is 17, and that of registered domestic “anti-hair loss“ cosmetics is 54.
【Requirements for efficacy evaluation measurement of anti-hair loss】
From 1 January 2022, cosmetic registrants shall evaluate the cosmetic efficacy claim in accordance with the requirements when applying for the registration of anti-hair loss special cosmetics. Meanwhile, in February this year, Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products has been added into Safety and Technical Standards for Cosmetics.
Adopt 60 times hair combing method, judgment of test results of anti-hair loss measurement: there is no significant increase in hair loss count before and after the use of test products or, the Difference value(the hair loss count at a visit time point after the use of product – the hair loss count before the use of product) of hair loss count before and after is significantly lower than the control group（P<0.05).
Or the hair density(Overall hair density or local hair density) has no significant decrease, or Difference value(the hair density at a visit time point after the use of product – the hair density before the use of product) of hair density before and after is significantly higher than the control group(P<0.05). Then the test product is affirmed to have the efficacy of anti-hair loss, otherwise it is affirmed to have no anti-hair loss efficacy.
(Details for the method: 6 Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products, Chapter 8 Efficacy Evaluation Method for Human Trial, Safety and Technical Standards for Cosmetics (2015 Edition))
【Dossier requirements for anti-hair loss cosmetic products】
According to Article 19 in CSAR, when applying for registration of special cosmetics the following dossiers shall be submitted
(1) the name, address and contact information of the registration applicant;
(2) the name, address and contact information of the manufacturing enterprise;
(3) product name;
(4) product formulation or the full composition of the product;
(5) executive standards for product ;
(6) product label sample;
(7) product inspection report;
(8) product safety assessment data.
Where the registration of imported special cosmetics or the notification of imported general cosmetics is applied, the documents certifying that the products have been listed and sold in the producing country (region) and the documents certifying that the overseas manufacturing enterprises comply with the standards for the quality management of cosmetics production shall be submitted at the same time; where the documents certifying that the products have been listed and sold in the producing country (region) can not be submitted for the purpose of export production to China, the data of relevant research and test conducted for Chinese consumers should be submitted.
The registration applicant shall be responsible for the authenticity and scientificity of the dossiers submitted.
For further information: info@zmuni.com
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ZMUni Chinese Cosmetic Regulation Compliance Centre 中贸合规中心
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