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The State Council of China published the Regulation on the Supervision and Management of Cosmetic Products (化妆品监督管理条例) (2020 regulation) on 29 June 2020. The 2020 regulation repeals and replaces the Supervisory Regulations on the Hygiene of Cosmetic Products (化妆品卫生监督条例) of 1989, as last amended in 2019. The 2020 regulation will become effective on 1 January 2021.
Verisk 3E Review
The regulatory framework governing cosmetics in China is currently established under the Supervisory Regulations on the Hygiene of Cosmetic Products (化妆品卫生监督条例) of 1989 (1989 regulation). When compared with the current framework, the following major revisions will be introduced under the 2020 regulation as of 1 January 2021:
- Amended scope of application for the 2020 regulation. Specifically, the 2020 regulation clarifies that toothpastes will be subject to the regulatory requirements for general cosmetic products. It also specifically excludes soaps from its application scope. Please note that soaps that bear efficacy claims of special cosmetics will be subject to the requirements under the 2020 regulation
- Revised product classification system. Under the 1989 regulation, cosmetic products are classified into two major types: special purpose cosmetics and other cosmetics. The 2020 regulation will revise this classification and divide regulated cosmetic products into the following categories: special cosmetics and general cosmetics. Different regulatory requirements will apply to products falling under these categories as follows:
- Manufacture and import of special cosmetics will be subject to the product registration requirements as prescribed under the 2020 regulation; and
- Manufacture and import of general cosmetics will be subject to the product notification/filing requirements as prescribed under the 2020 regulation
- (Detailed information on the procedures for submitting a product notification or registration petition can be found under Chapter Two of the 2020 regulation.)
- Amended regulatory requirements for new ingredients of cosmetic products (i.e., ingredients that are used in cosmetic products for the first time in China, including natural and synthetic ingredients). Under the 2020 regulation new cosmetic ingredients will be handled through two different methods. Specifically, ingredients that function as preservatives, sunscreens, coloring agents, hair dyes, freckle removers and skin whitening products will be subject to registration requirements. All other new ingredients for cosmetics will only need to be notified to the National Medical Products Administration before being used in China. Under the 1989 Regulation all new cosmetic ingredients must be registered before they may be used in China
- It is clarified that companies intending to file a petition for cosmetic products or new ingredients will need to conduct a safety evaluation of these products before they may file this petition or application. This safety evaluation may be conducted by the petitioner or a qualified third-party institution
- Special requirements will be imposed on companies that outsource their production operations. For instance, contracted cosmetic manufacturing facilities must hold a Production Permit for Cosmetics
- Cosmetic manufacturers that are located outside of China will need to appoint a representative in China to handle issues in relation to notification petitions or registration applications for their products. These representatives are required to support the efforts in monitoring any side effects of the concerned products and conducting recalls when necessary; and
- Labeling requirements for cosmetic products will be further elaborated. Articles 35 through 37 prescribe general labeling requirements for cosmetics, including mandatory information on a product label and information prohibited from being included on the product label
Verisk 3E Analysis
Companies that manufacture or import cosmetics should note that China has recently repealed and replaced its framework legislation for cosmetics. This update introduces amendments to the regulated products under the framework regulation for cosmetics. Applicable regulatory requirements to these regulated products, including product registration, notification and labeling requirements are also revised or further detailed, as compared to the current framework regulation for cosmetics. The new regulation will become effective on 1 January 2021. Affected parties need to review the changes under the 2020 regulation and adjust their business practices accordingly to ensure compliance.