SAMR Issued the Provisions for Registration and Notification of Cosmetics

To implement the newly revised Regulations on the Supervision and Administration of Cosmetics (hereinafter referred to as the Regulations), reinforce the administration of cosmetics registration and notification, protect consumers’ health rights, and standardize and promote the healthy development of the cosmetics industry, the NMPA drafted the Provisions for Registration and Notification of Cosmetics (hereinafter referred to as the Provisions). The Provisions has been adopted upon deliberation at the 14th Executive Meeting of the State Administration of Market Regulation on December 31, 2020, and shall go into effect as of May 1, 2021.

The revised Regulations has established a registration and notification administration system with the registration persons and notification persons as the subject of liability for quality and safety, clarified the procedures and requirements for the registration and notification of cosmetics and new cosmetic ingredients, and determined a series of new concepts, systems and mechanisms, which necessitate the formulation of supporting provisions to further elaborate cosmetics registration and notification administration. During the drafting of the Provisions, the NMPA held multiple symposiums, on-site surveys and special discussions, and extensively listened to the opinions and suggestions of local regulatory authorities, industry associations, enterprises, legal and technical experts from all social sectors. Emphasizing on the “Four Strictest” requirements in a practical way of problem orientation, the Provisions elaborates the principles and systems determined in the Regulations, with a view to strictly implementing review and approval as well as notification administration, reinforcing risk control, deepening the reform of “streamlining administration, delegating more powers to lower-level governments and society and improving regulation and optimizing services”, encouraging R&D enterprises to innovate, optimizing the registration and notification procedures, and implementing the principal responsibilities and supervision responsibilities of various parties. With a total of 63 Articles in 6 Chapters, the Provisions covers:

1. The elaboration on the administration system for registration and notification persons to potentiate corporate principal responsibilities. In accordance with the related requirements of the Regulations, detailed provisions for responsibilities, obligations and access conditions are applied to registration and notification persons of cosmetics and new cosmetic ingredients to potentiate the supervision and liability of product at its source. A safety monitoring system for new cosmetic ingredients is established with detailed regulations on the safety monitoring obligations of registration and notification persons of cosmetics and new cosmetic ingredients.

2. The optimization of the registration and notification administration procedures and concretization of reform measures for the review and approval system. As per the relevant provisions of the Regulations and the reform of “streamlining administration, delegating more powers to lower-level governments and society and improving regulation and optimizing services”, the registration and notification administration procedures are further clarified and optimized on the basis of summarizing the experience drew from the reform implemented in the previous stage, such as the transition from review and approval to notification of imported general cosmetics, and the adjustment of special cosmetics to the informing&pledging system for registration renewal.

3. The enhancement of supervision and administration of post-notification to ensure that the responsibilities for product quality and safety are in place. The responsibilities and requirements for the supervision and administration of postnotification are clarified, with stricter penalties for violations of laws and regulations on filed products, which are subject to classification management to rationally allocate supervision resources.

4. The establishment of an innovationencouraging mechanism to serve the highquality development of the industry. The relevant provisions of the Regulationson encouraging innovative development are further elaborated, clarifying that during the safety monitoring period, no cosmetics registration persons and notification persons can use the new cosmetic ingredient without the consent of its registration person or notification person so as to protect the enthusiasm of enterprises in new ingredient R&D; Greater efforts are made to construct the information technology for registration and notification, multi-functional information service platforms shall be built to improve the efficiency of registration and notification, so as to accelerate product marketing, and promote the steady improvement of the high-quality development of the cosmetics industry.