On June 29, 2020, The State Council promulgated the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the CSAR), which will take effect from January 1, 2021. The National Medical Products Administration is making and revising departmental rules and normative documents of the CSAR, and deliberating and releasing 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, relevant matters concerning the implementation of the CSAR are hereby announced as follows:
I. Cosmetics Registrants and Filers
Since January 1, 2021, companies or other organization that holds special use cosmetics registration certificate (special-use cosmetics administrative licensing certificate) or have already dealt with the filing of ordinary (non-special use) cosmetics shall be responsible for the quality, safety and efficacy claims of the cosmetics in accordance with the requirements for the cosmetic registrants and filers of the CSAR.
II. Cosmetics Registration and Record Keeping Management
Since January 1, 2021, cosmetics and new cosmetics raw materials shall be managed under the classifications. Before the issuance and implementation of the relevant provisions on the registration and filing of the CSAR, cosmetics registrants and filers shall submit registration and filing materials in accordance with the current provisions on the registration and filing. The registrants and filers of new cosmetics raw materials shall submit registration and filing materials in terms of the dossier requirements of the Guideline for the Notification and Evaluation of New Cosmetics Ingredients. The filing work is finished once the filers of the cosmetics and new cosmetic ingredients submit the filing materials. The medical product administration department shall carry out the relevant registration management work in accordance with the procedures and timelines stipulated in the CSAR.
For special cosmetics approved after January 1, 2021, the product registration certificate shall be valid for 5 years.
III. Transitional Management of Five Categories of Special-use Cosmetics
As of January 1, 2021, cosmetics such as hair growth, depilation, breast shaping, bodybuilding and deodorization will no longer be managed according to special cosmetics, and the NMPA will no longer accept the registration application of related products, and issue the relevant administrative approval license. If an application for the administrative license has been accepted but the administration approval decision has not been made, NMPA shall terminate the review and approval of the products which are considered as ordinary cosmetics or non-cosmetics according to the CSAR. For the products belonging to special cosmetics under the CSAR, the applicant may submit the revised materials to continue to application procedures.
IV. Management of Soap and Toothpaste
Since January 1, 2021, soaps claiming the function of special cosmetic shall be registered as special cosmetic in terms of the CSAR.
Prior to the release and implementation of the relevant regulations on the supervision and administration of toothpaste, the medical products administration department shall supervise the toothpaste according to the current relevant regulations.
V. Evaluation of Efficacy Claims and Label Management
Before the release and implementation of the cosmetics classification rules and catalogs, standards for the evaluation of cosmetics efficacy claims and measures for the management of cosmetics labels, cosmetics registrants and filers do not need to publish the summary of product efficacy evaluation data for the time being, and the management of cosmetics efficacy claim evaluation and label is implemented in the light of the current relevant provisions.
VI. Licensing of Cosmetics Production
From January 1, 2021, the cosmetics production license previously obtained shall remain valid within the validity period, and the new production license application and the alteration, extension and reissuance of the production license shall be implemented under the provisions of the CSAR. Before the release and implementation of the relevant regulations on the production license administration of cosmetics, the dossier requirements for the application of the cosmetics production license shall be implemented according to the Work Specification for the Production License of Cosmetics, and a new version of the cosmetics production License shall be issued. The sample of the new certificate is shown in the attachment. For the areas where e-certs are issued and used, the e-certs should be the same as the new paper certificates.
VII. Investigation and Punishment of Illegal Acts
The Regulations Concerning the Hygiene Supervision of Cosmetics still apply to the illegal behaviors that occur before January 1, 2021. However, the CSAR shall be applicable to those that are not regarded as illegal or should be given a lighter punishment in terms of the CSAR. If the illegal act occurs after January 1, 2021, the CSAR will be a reference for the punishment.
Cosmetics Production License
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