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Editor's Note: This article was originally published on Jan. 21, 2023, and was updated on Mar. 8, 2023, as per the latest developments.
Latest Updates
On Mar. 1, 2023, China National Medical Products Administration (NMPA) implemented Measures for the Management of Cosmetic Sampling Testing.
In September 2020 and June 2022, China NMPA issued two drafts of Measures for the Management of Cosmetic Sampling Testing (Measures). Finally, on January 12, 2023, NMPA released the finalized Measures, which will be implemented on March 1, 2023. 1
The Measures is divided into 8 chapters and 61 articles, providing detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure. The key points are summarized and analyzed as follows.
Sampling Methods
To strengthen the supervision of cosmetic manufacture and operation in China, local medical products administration departments (MPAs) will organize the sampling testing according to their annual sampling testing plans.
Special personnel will be assigned to carry out the sampling through on-site sampling or online product sampling. Recognized testing institutions will be responsible for the sample testing.
During on-site sampling, the sampling personnel shall show the sampling work certification documents to the manufacturers and operators of the sampled cosmetics;
Online product sampling shall simulate the online shopping process, which means the sampling personnel shall not inform the manufacturers and operators of the purchase purpose.
With the development of e-commerce in recent years, online sales have become the main sales channel of cosmetics. It’s worth mentioning that the standardization of online product sampling requirements will be conducive to the development of the cosmetic industry. Unqualified products that are only sold online will have nowhere to escape under strict sampling testing requirements.
Sampling Procedures
The Measures makes detailed provisions on sampling procedures, as well as the rights and obligations of the competent authorities, testing institutions, manufacturers and operators, etc., during the sampling process. The whole process of sampling testing is shown in the figure below:
Sampling Procedures
Six Key Sampling Categories
Cosmetics sampling testing shall focus on the following products:
Children's cosmetics and special cosmetics;
Cosmetics added with new ingredients;
Those found to have many problems in supervision and inspection, case investigation, adverse reaction monitoring, safety risk monitoring, complaint and report, public opinion monitoring and other supervision and administration work;
Those with a high unqualified rate in past sampling testings;
Those with a wide scope of circulation and high frequency of use;
Other products with high safety risks.
With the loosening of pre-market requirements for new cosmetic ingredient (NCI), more than 40 NCIs were notified in 2022. Meanwhile, NMPA is strengthening the post-market surveillance of cosmetic products added with notified NCI. As a result, the sampling frequency of such products will increase.
Products with a wide range of circulation and high frequency of use are also key sampling targets, indicating that famous products circulating in the online market will receive more regulatory attention.
Five Abnormal Situations of Sampling
For cosmetics subject to the following 5 types of abnormal situations of sampling, the sampling units shall file a case for investigation or notify the medical products administration department with jurisdiction:
Unregistered special cosmetics, unnotified marketed or imported general cosmetics;
Those exceeding the durability;
Those without a Chinese label;
Those labeled with prohibited contents;
Other cosmetics suspected to be illegal.
Disposal Measures
The Measures also clarifies the verification and disposal process of unqualified products. The departments for the verification and disposal of unqualified products shall,
within 15 working days from the date of receiving the testing result, file a case for investigation of the involved cosmetics manufacturers and operators;
during the sampling, if finding any prohibited ingredient or substance that may endanger human health, the departments for the verification and disposal of unqualified products shall immediately file a case to investigate the involved cosmetics manufacturers and operators.
If a product is found to cause human injury or there is evidence showing that it may endanger human health during the investigation, the production and operation of the involved products shall be suspended. In case of serious risks and hidden dangers found in the cosmetics production quality management system, the production and operation of all relevant products of the enterprise shall be suspended.
In addition, the content proposed in the previous draft that "According to law, overseas cosmetics registrant and notifier who refuses to fulfill the relevant administrative penalty decision will be prohibited from importing the cosmetics within 10 years" was deleted in the finalized Measures.
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