A few days ago, China’s National Medical Products Administration (NMPA) released a Circular on the Standards of Cosmetics Registration, Record-Filing, Inspection, and Test (NMPA Circular [2019] No.72). This Circular indicates some important updates about the registration, record-filing, inspection and test items of cosmetic products and stipulates that only qualified laboratories can register themselves in the NMPA’s management system to take charge of cosmetics registration, record-filing, inspection and tests.
The new management system is already established
In the past, cosmetics manufactured in China were required to undergo inspection and tests in laboratories designated by the China Food and Drug Administration (CFDA).
According to the new regulation, from September 10, only eligible laboratories must submit relevant information to a new online system Cosmetics Registration, Record-Filing, and Inspection Management System to be registered to undertake cosmetics registration, record-filing, and inspection. Also, from November 1, 2019, these CFDA-designated laboratories will not be allowed to conduct cosmetics registration, record-filing, and inspection.
The NMPA will publish the name, address, contact information, and competence scope of the qualified laboratories online very soon. Then, cosmetics enterprises can directly query relevant information about the laboratory online and select one with corresponding inspection capabilities to carry out the registration, record-filing, and inspection of the cosmetic product.
Registration with the CFDA
CFDA will test all health supplements and ensure that the medical products are safe, effective, and meet the quality standards before they issue or withdraw the Registration Certificate if the supplement is found to cause adverse reactions or is harmful to the human body. Any health supplement without a Registration Certificate is prohibited from being manufactured, imported, sold, or used in China, and those that have been manufactured or imported should be destroyed or disposed of under the supervision of the local CFDA.
Both imported and locally produced health supplements will go through check and registration with the government. The China Food and Drug Administration (CFDA) is in charge of the inspection and supervision of the safety of medicine, medical devices, cosmetics, and supplements. Vitamins and supplements need to obtain an additional mark from the CFDA. The mark, normally referred to as “blue hat”, consists of the characters “保健食品 (supplements in Chinese)” written in a blue font with a standard code beginning with “国食健字J” for imported health supplements; “国食健字G” for health products made in China.
Regulation of the inspection and test items
The Circular has changed the original cosmetic inspection and test items in hygiene, pathology, human body safety, efficacy evaluation inspection, and other aspects. Cosmetic enterprises and inspection institutions should refer to Annex 1 of the Circular No.72 to identify inspection items of the cosmetic product.
Products that were registered before September 10, but whose inspection items are inconsistent with standards specified in the Circular will require their inspection to be supplemented within one year.
For cosmetics registered after September 10 that haven’t been tested, the inspection and tests must be carried out as per the new standards in the Circular.
Between September 10 and October 31, 2019, cosmetics enterprises can either select a laboratory that has been published on the NMPA system to finish cosmetics registration, record-filing, and inspection online or follow the original procedures, offline, through a CFDA-designated institution.
If the inspection and tests have already been undertaken or an overseas laboratory has completed the inspection and issued an inspection report, the report can be used in the registration or filing of cosmetics.
Further, the supplementary inspection report must be submitted at the time of the application for an extension of the validity of the product’s administrative license or provided for future reference when the product is put on record to confirm the continuation of production.
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