Final Publication of the “Regulations on the Supervision and Administration of Cosmetics” and New Prospectives of Cosmetic Science in China

Abstract

In June 2020, the new “Regulations on the Supervision and Administration of Cosmetics” (CSAR) was finally issued and published in China. This is the first revision of the “Regulations on Hygiene Supervision of Cosmetics” (CHSR) since its publication in 1989. As the basic and fundamental legislation for cosmetics, CSAR has a far-reaching impact on the whole industry and also reveals new trends in scientific research work. To provide an interpretation of this regulation and help enterprises and researchers better understand the new policies, in this study, the main contents of CSAR and its regulatory system were introduced, and the major changes and background considerations were summarized, especially in the definition and scope of cosmetics, classification and categorization, ingredient management, safety evaluation, efficacy substantiation and technical evaluation work. A brief review of technical progress worldwide and a comparison of regulatory requirements were provided where necessary. Finally, new prospects of cosmetic science in China were discussed. In conclusion, CSAR will initiate a renewed and integrated regulatory system for cosmetics. Advanced concepts of supervision, encouragement of innovation, utilization of technical approaches and emphasis on scientific investigations are reflected in the regulations, which will deeply influence the development of both cosmetic products and new ingredients. With all these new challenges and opportunities, everyone involved should get prepared.

Overview of Cosmetic Regulatory Frameworks around the World

“…The new cosmetic regulation, Cosmetic Supervision and Administration Regulation (CSAR), was implemented on 1 January 2021, replacing the former Cosmetics Hygiene Supervision Regulations (CHSR), from 1990. As a follow up to this general regulation, several subsidiary regulations have been announced, notably related to the registrations and notification process, good manufacturing practices (GMPs), and monitoring of adverse reactions, among others [10,11].…”

“…Each layer is represented by a 2-digit number or letters which are arranged together to form a code for a specific product. For example, a hair shampoo made especially for infants can get a code of 01-01-03-02-01, which means "clean-hair-liquid-infants-rinse off" [10].…”

“…If a product meets the regulatory definition of soap, it is considered a consumer product and regulated by the Consumer Product Safety Commission (CPSC), instead of by the FDA; otherwise, it is either considered a cosmetic, a drug, or both, depending on the relevant criteria [18,23]. Furthermore, in China, soaps are free of supervision by CSAR, except those that claim to have special cosmetic efficacy (e.g., whitening) [10]. Sunscreen is another example of a product with distinct classifications in different countries.…”

“…Under China's new regulations, special cosmetics need to be registered and approved by NMPA before production while general cosmetics can be directly put on the market after a notification. However, since 1 January 2022, before registration or notification, the registrant or notifier shall either perform a self-assessment safety evaluation or entrust this task to a professional agency, and submit the product safety assessment documents during registration and notification [10].…”

“…Ingredients are also divided into different risk levels. Those considered to be relatively high-risk (preservatives, UV filters, colorants, hair dyes and (hyper)pigmentation removal or whitening agents) require a registration with NMPA to obtain approval while the others can be immediately used after notification to NMPA [10].…”