On April 26, 2023, the Shanghai Medical Products Administration (Shanghai MPA) issued the first customized cosmetics manufacturing license in China for a store in Pudong New Area (Shanghai MPA license).  Customized cosmetics are products that can be tailored to individual customer preferences and skin types onsite at a retail store, which an increasing number of cosmetic brands have been exploring.  The Shanghai MPA license is for on-site customized service for “ordinary liquid cosmetics” (excluding children’s cosmetics and skincare cosmetics for eyes), and is valid for five years from the date of issuance.

The Shanghai MPA license follows the issuance of new policies and trial regulations in the area of customized cosmetics by China’s National Medical Products Administration (NMPA) and certain local Medical Products Administrations (MPAs).  In November 2022, NMPA issued a notice that officially opened the door for customized cosmetic services by launching a one-year pilot program in Beijing, Shanghai, Zhejiang, Shandong, and Guangdong provinces and directly-administered municipalities.  This notice encourages companies to explore personalized cosmetics services in color cosmetics and skincare, including skin testing, product tracking, and customized skincare services.  It also directs the local MPAs in the pilot districts to each select three registrants as pilot personalized service enterprises, and encourages the local MPAs to develop supervision requirements covering customized cosmetics product filing, testing, sample retention, and sales management.

The Shanghai MPA subsequently issued a draft local rule for the Pudong New Area, setting forth certain parameters for customized cosmetic services licenses.  The draft local rule defines on-site customized cosmetic services as “ordinary cosmetic filers and their domestic responsible persons, providing repackaging and packaging services on site according to consumers’ personalized needs, which involve direct contact with cosmetic contents in a special area on their business premises.”  Cosmetic stores can submit applications to the Shanghai MPA for a special customized cosmetic manufacturing license with “on-site customized service” as part of its scope.  Failure to obtain this special license can result in penalties for formulating customized cosmetics without approval.  Cosmetics resulting from on-site customized services must still complete pre-market record-filing procedures.  The draft local rule excludes special cosmetics, children’s cosmetics, skin care cosmetics for eyes, and cosmetics using new ingredients; these cosmetics are not eligible for customized cosmetics licensure.

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Contributors: John Balzano, Julia Post, Muyun Hu, Annie Wang, and Kaixin Fan