Cosmetic companies should become familiar with the newly approved Chinese regulation on the supervision and administration of cosmetics, which is expected to make a significant impact on the industry once it enters into force early next year.
The Cosmetic Supervision and Administration Regulation (CSAR) was approved by the Ministry of Justice of China on July 29, 2020 after five years, replacing the existing Cosmetics Hygiene Supervision Regulations (CHSR) released in 1989.
Changes under CSAR include a unified filing system for domestic and imported special cosmetic products, new cosmetic ingredient registration and management, new rules on efficacy testing and claim substantiation, and safety risk assessment and exemption from mandatory animal testing, said cosmetics regulatory consulting and testing company CE.way in a release.
Under the new rules, special cosmetic products will refer to cosmetics with special purpose or function. Covered are hair dyes, anti-hair loss products, hair perms, skin whitening products, sunscreen products and products with new efficacies and functions as determined by National Medical Products Administration (NMPA), according to testing and certification service provider SGS.
Special cosmetic products are subject to pre-market registration, while general cosmetics, which refer to cosmetics other than special cosmetic products, only require filing.
Further, general cosmetics will no longer be subject to mandatory animal testing, whether produced domestically or imported into China. Safety assessments will be accepted in place of animal testing.
However, animal testing is required for products intended for use by children or infants and products with new ingredients which have been approved but are not yet listed in the Inventory of Existing Cosmetic Ingredients in China.
Toothpastes are now considered general cosmetics and are regulated under CSAR. Notification to NMPA is required before launching to the market.
Soaps remain outside of the scope of CSAR, except soaps with special cosmetic efficacy. For example, soap with a skin whitening function will be considered a special cosmetic and needs registration.
Under CSAR, cosmetic ingredients are classified as “new” and “used” ingredients. New raw materials with high risk, such as preservatives, sunscreens, whitening agents, colorants, and hair dyes, require registration and approval from NMPA. Other new ingredients are subject to filing with NMPA.
On quality control and safety assessment, the new regulation states that personnel responsible for safety assessment shall possess relevant professional knowledge in the field of cosmetic quality and safety, and shall have more than five years of relevant working experience.
Personnel responsible for cosmetic quality and safety shall possess relevant professional knowledge and shall have more than five years of relevant working experience in the field of quality and safety control or production management.
In addition, cosmetic claims must be substantiated by sufficient scientific evidence, which will be made publicly available on the NMPA’s website.
Imported cosmetic products also need to submit certifications relating to manufacturing quality control of the overseas manufacturers as well as documents that prove those products have been placed on the market in the country of origin.
For products specifically produced for China, the applicant must provide research and test data for Chinese consumers.
Since the new CSAR contains many new requirements, a five-year grace period is granted for already registered hair growth, hair removal, breast beauty, slimming, and deodorant cosmetics from the date of implementation of this regulation. The production, import, and sale of these products are prohibited after the transition period.
The new regulation will be implemented on January 1, 2021. Following the release of CSAR, China will publish a series of supporting documents and administrative rules to further establish the country’s cosmetic regulatory framework.