(Sept. 10, 2020) On June 29, 2020, China’s State Council (cabinet) published an overarching regulation governing the production of cosmetics and the operation of cosmetic companies in the country, the Regulation on Supervision and Administration of Cosmetics. Taking effect on January 1, 2021, the long-awaited new Regulation will repeal the 1989 Regulation Concerning the Hygiene Supervision over Cosmetics, the country’s primary cosmetic regulation that has been in place for over thirty years since January 1, 1990. The new Regulation was previously passed by the State Council on January 3, 2020, and signed by the premier on June 16, 2020.
The 80-article Regulation defines “cosmetics” as any daily chemical products intended to be applied on the skin, hair, nails, lips, or other surfaces of the human body by spreading, spraying, or other similar methods, for cleaning, protecting, beautifying, or grooming purposes. (Art. 3.) Highlights of the new Regulation include the classification of cosmetics into two groups for regulatory purposes; identification of a Responsible Person to ensure product quality, safety, and efficacy; requirements for cosmetic manufacturer licensing; and adverse event reporting procedures.
- Classification of Cosmetics
The Regulation groups cosmetic products into “special use cosmetics” and “general use cosmetics,” and subjects the two groups to different pre-market registration or filing requirements. The first group contains hair dyes, hair-perming products, freckle-removing and whitening products, sunscreens, and any other products claiming to have new efficacies. Other cosmetic products are considered general use cosmetics. (Arts. 4 & 16.)
Under the Regulation, special use cosmetics are subject to registration with the National Medical Products Administration (NMPA) before being allowed to be manufactured or imported into China. Production of general use cosmetics are subject to filing procedures with the medical products administration (MPA) at the provincial level, and the import of general use cosmetics requires filing with the NMPA. (Art. 17.)
- Responsible Person
The applicant for the cosmetic product registration or filing is responsible for the quality, safety, and efficacy of the product (hereinafter “Responsible Person”). (Art. 6.) Prior to the registration or filing of a cosmetic product, the Responsible Person must perform a product safety assessment by itself or through a professional institution. The safety assessment must be performed by persons having expertise related to cosmetics quality and safety plus five years’ relevant work experience. (Art. 21.) A Responsible Person may produce the product on its own or entrust other manufacturers to produce the product. (Art. 28.)
- Cosmetics Production License
Manufacturers must apply for a cosmetics production license from the provincial MPA. The license is valid for five years and may be renewed in accordance with the law. (Art. 27.)
When applying for the license, a manufacturer must submit materials to prove that it
- is a legally incorporated enterprise;
- has proper production sites, environments, and production facilities and equipment for the types of cosmetics to be produced;
- has technical personnel suitable for cosmetics production;
- has inspectors and facilities for quality inspection of the cosmetics to be produced; and
- has a safety management system. (Art. 26.)
- Adverse Event Reporting
If a cosmetic product has quality defects or may otherwise present a risk to human health, the Responsible Person must immediately stop the manufacturing activities, recall the products, and notify retailers and consumers, among other measures prescribed by the Regulation. The Responsible Person must also report the recall and measures taken to the provincial level MPA. (Art. 44.)
The NMPA is expected to issue a series of administrative rules to implement the Regulation. On July 21, 2020, the NMPA published the 88-article draft Measures on the Administration of Cosmetic Registration for public consultation.