On December 17, 2021, China NMPA (National Medical Products Administration) issued an announcement on matters related to further clarify the management of the original special use cosmetics during the transition period (No.150, 2021), the announcement details are as follows:
1. Management of five categories of original special-use cosmetics such as hair growth during the transition period
The products that have obtained the administrative license approval for five categories of original special use cosmetics, including hair growth, depilatory, breast beauty, body-building, and deodorant in accordance with the Regulations Concerning the Hygiene Supervision Over Cosmetics have been stipulated a unified transition period until December 31, 2025, according to Article 8 of the Cosmetics Supervision and Administration Regulations. During the transition period, cosmetic registrants can apply for cancellation of administration license approval for categories of original special-use cosmetics such as hair growth. In addition, NMPA will no longer accept applications such as changes, reissues, or renewals of related products. If there is any change in matters that do not involve safety and efficacy claims, the cosmetic registrants shall promptly apply for filing to NMPA.
During the transition period, after the expiration of administration license approval for the five categories (including hair growth) of original special-use cosmetics, the related products can still be produced, imported, and sold until the expiration of the transition period. After the administrative license approval for related products is cancelled, the cosmetic registrants and filing persons can apply for registration for special cosmetics, filing for general cosmetics in accordance with the Cosmetics Supervision and Administration Regulations, Provisions for Registration and Filing of Cosmetics and other relevant regulations. After obtaining the registration certificate or completing the filing, the related products will not be managed according to the requirements of the transition period. If the formula, technical requirements, and other safety contents of the related products no longer meet the requirements of the mandatory national standards and technical specifications for cosmetics, the products shall not be produced, imported, or sold.
2. Registration and filing management of products related to the update of the catalogue of raw materials banned for cosmetics
In order to further strengthen the management of cosmetic raw materials and ensure the quality and safety of cosmetics, NMPA issued an Announcement on Updating the Catalogue of Raw Materials Banned for Cosmetics (No.74, 2021, hereinafter referred to as the Catalogue) on May 26, 2021. The catalogue of raw materials banned for cosmetics has been updated. According to the announcement, as of the issuance of the announcement, cosmetic registrants and filing persons shall not produce and import products that have used prohibited raw materials specified in the Catalogue.
Cosmetics have obtained the registration certificate or completed the filing before the issuance of the announcement, and used the newly added raw materials banned for cosmetics after the update of the Catalogue, the cosmetic registrants and filing persons can retain the original registration and filing number by changing the formula, replacing or deleting the corresponding raw materials banner for cosmetics. If the original registration or filing number is to be retained, the registrant and filing applicant shall, before May 1, 2022, submit an application for formula change in accordance with the registration and filing change procedures stipulated in the Provisions for Registration and Filing of Cosmetics, and submit inspection reports, safety assessment reports, and other related safety materials in accordance with material regulations of the new product registration and filing. For products that have completed the renewal of the administration license approval of original special-use cosmetics, the registrants can submit a change application according to the above requirements before the technical review conducted by NMPA. If the registrants fail to apply for a change within the prescribed time limit, the related products shall not continue to be sold.
3. Renewal management of the validity period of the special cosmetic registration certificate
If the validity period of the special cosmetic registration certificate (including the administration license approval of original special use cosmetics) expires and needs to be renewed, the registrant shall conduct a comprehensive self-inspection and evaluation of the product from 6 months before the expiration of the registration certificate. If the results of self-inspection and evaluation of the product comply with the relevant regulations, registrants or domestic responsible persons shall apply for a renewal of cosmetic registration within the specified time limit according to the Provisions through the Information Service Platform for Registration and Filing of Cosmetics, and submit the corresponding application materials in accordance with the relevant requirements.
If the application for registration renewal fails to submit application materials within the specified time limit due to the force majeure and reasons other than cosmetic registrants or domestic responsible persons, the registrants or domestic responsible persons shall submit a written statement of the situation with corresponding supporting materials to local provincial MPA within 10 working days after the impact of the epidemic is eliminated. The local provincial MPA shall verify and issue a written opinion within 10 working days from the date of receiving the written statement. The registrants or domestic responsible persons shall, within 5 working days from the date of receiving the written opinion, apply for registration renewal to the NMPA administrative acceptance agency, and submit application materials and the written opinion issued by the provincial MPA.
As of the date of this announcement, the NMPA announcement on issues related to the implementation of the renewal commitment system for the administrative license approval of special-use cosmetics (No.45, 2019) will be abolished simultaneously.