Announcement of National Medical Products Administration on The Implementation of the Cosmetic Supervision and Administration Regulation (2020, No. 144)
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Release time: Dec. 28th,2020
On June 29, 2020, The State Council promulgated the Cosmetic Supervision and AdministrationRegulation (hereinafter referred to as the Regulation), which will take effect from January 1st 2021. The National Medical Products Administration is organizing the formulation and revision of the supporting departments’ regulations and normative documents of the Regulation, and is reviewing and issuing them in accordance with relevant legislative procedures. In order to ensure the quality and safety of cosmetics and promote the healthy development of the cosmetics industry, the relevant matters concerning the implementation of the Regulation are announced as follows:
I. About cosmetics registrants and filing persons
From January 1st 2021, all enterprises or other organizations that hold a special cosmetics registration certificate (approval for special-use cosmetics administrative license) or have filed for general cosmetics (non-special use cosmetics) shall be responsible for the quality, safety and efficacy claims of cosmetics in accordance with the requirements of the Regulation on cosmetics registrants and filing persons.
II. About cosmetics registration and filing management
From January 1st 2021, the classification management of cosmetics and new cosmetic raw materials will be implemented. Before the relevant supporting regulations of registration and filing are issued and implemented, the cosmetics registrants and filing persons should submit registration and filing documents in accordance with the current regulations. The new cosmetic raw material registrants and recorders should submit registration and record data in accordance with the required information in “Guidelines for the Application and Review of New Cosmetic Raw Materials”. The cosmetics and new cosmetics raw materials filing person will complete the recordation after submitting the filing documents; the Medical Products Administration and Management Department will carry out the registration management related work in accordance with the procedures and time limits stipulated in the Regulation.
For special-use cosmetics whose registration decision is made after January 1st 2021, the product registration certificate is valid for 5 years.
III. About the transition period management of five types of special-use cosmetics
From January 1st 2021, hair growth, hair removal, breast beauty, body fitness, and deodorant cosmetics, the five kinds of special-use cosmetics specified in the Cosmetics Hygiene Supervision Regulations will no longer be managed as special cosmetics. The National Medical Products Administration will no longer accept related registration applications of them, and the relevant special cosmetics administrative license approval documents will no longer be issued. Previously accepted administrative license applications that have not yet made an administrative license decision, according to the Regulation, if products are belong to non-special use cosmetics or not be regarded as cosmetics, The National Medical Products Administration will terminate the review process; if products are still regarded as special cosmetics, the applicant can continue to review and approve the application in accordance with the procedure after adjusting the application materials.
IV. About soap and toothpaste management
From January 1st 2021, soaps claiming to have special function shall apply for special cosmetic registration and obtain registration certificate in accordance with the Regulation.
Before the release and implementation of the relevant regulations on the supervision and administration of toothpaste, the National Medical Products Administration Department will supervise and administer the toothpaste in accordance with the current relevant regulations.
V. About the evaluation of efficacy claims and label management
Before the Regulation supporting cosmetic classification rules and classification catalogs, cosmetic efficacy claims evaluation standard, cosmetics label management measures, etc. are issued and implemented, cosmetics registrants and filing person do not need to publish a summary of product efficacy study, cosmetic efficacy claims evaluation and label management are implemented in accordance with current relevant regulations.
VI. About cosmetics production license
From January 1st 2021, the previously obtained “Cosmetics Production License” will continue to be valid within the validity period. The new cosmetic production license and the alteration, renewal, and reissue of the license will be implemented in accordance with the provisions of the Regulation. Before the supporting cosmetics production license management regulations are issued and implemented, the requirements for cosmetics production license materials shall be implemented in accordance with the “Cosmetic Production License Work Standard”, and a new version of the “Cosmetics Production License” will be issued. The certificate format is shown in the attachment. In areas where electronic certificates are issued and used, the format of the electronic certificate should be consistent with the new version of the paper certificate.
VII. About the investigation and punishment of illegal acts
The cosmetic violations occur before January 1st 2021 apply to the “Regulations on Cosmetics Hygiene Supervision” , but the Regulation will be applied if the regulations are deemed not illegal or should be given a lighter punishment. The illegal act occurs after January 1st 2021 apply to thee Regulation.
It is hereby notified the above.
Attachment: Cosmetics Production License (Format)
National Medical Products Administration
Dec. 28th,2020
