After three decades of waiting, the Cosmetic Supervision and Administration Regulation (CSAR), the important overarching cosmetics regulation, came into force on January 1, 2021. This means that from January 1, 2021 onwards, all enterprises that hold a special cosmetics registration certificate or general cosmetics certificate are responsible for the quality, safety, and efficacy claims as required by the CSAR.
A new regulatory era begins as the CSAR replaces the old Cosmetics Hygiene Supervision Regulations (CHSR). However, there is a transition arrangement which means the regulatory requirements will come into force at different times depending on the product. In the interim, the old requirements continue to apply.
The most recent guidance relates to soap and toothpaste products, as well as products for hair removal, hair growth, breast shaping, body slimming, and deodorizing.
On December 28, 2020, the NMPA addressed (No.144 – 2020) several arrangements to support the launch of the Cosmetic Supervision and Administration Regulation (CSAR).
Responsibility of Cosmetic Filers and Registrants
From January 1, 2021 onwards, all enterprises that hold a special cosmetics registration certificate or general (non-special use) cosmetics certificate are responsible for the quality, safety, and efficacy of cosmetics as required by the CSAR.
Registration and Filing of Cosmetics
From January 1, 2021 onwards and before the regulations supporting the CSAR are implemented for the registration and filing of cosmetics and cosmetic ingredient, the applicants should continue to follow the existing regulations. The filing of cosmetics and cosmetic ingredients will be considered completed after the notification dossiers are submitted. In the past, it took five days for the online submission to be reviewed. There is no pre-market review on filing documents anymore.
For special cosmetics registered after January 1, 2021, the certificates will be valid for 5 years.
Managing 5 Product Transitions
From January 1, 2021 onwards, the NMPA will no longer consider hair removal, hair growth, breast shaping, body slimming and deodorizing products as special cosmetics. Any ongoing applications accepted or received before January 1, 2021, will be terminated and the NMPA will no longer issue special cosmetic licenses for these products. However, the products that have successfully obtained the special cosmetic licenses can continue to produce, import and sell in China until December 31, 2025. During the transition period, the NMPA shall address the further arrangements of these products. Stay tuned to our Cisema updates and insights.
Efficacy Claims and Labeling
Applicants can continue to follow the existing regulations temporarily before the CSAR regulations are announced and implemented for the cosmetics classification rules and catalogue, efficacy claim evaluation, labelling requirements etc.
Registration Measures of Soap Products
From January 1, 2021 onwards, soaps with efficacy claims of special cosmetics are required to register as special cosmetics according to the CSAR and obtain a registration certificate.
Filing Measures of Toothpaste Products
Before the CSAR regulations are implemented for the filing of toothpaste products, the NMPA and applicants should continue to follow the existing regulations.
On January 6, 2021, the NMPA released (No.4-2021) the draft for the filing dossier requirements of toothpastes and launched the public consultation to solicit comments. The draft addresses the requirements for toothpaste, including the filing dossier, classification, coding system, allowed efficacy claims, and efficacy evaluation and safety assessment requirements.
Applicants are required to submit the completed application form, product name, product formula, related product standards, product labelling draft, product testing report, and safety evaluation information.
If the labelling or IFU indicates any efficacy claims other than basic cleaning, the evaluation of the clinical efficacy shall be carried out.
In one of the draft’s attachments, a table of different efficacy claims for toothpastes covers basic cleaning, anti-decay, plaque prevention, desensitizing, reducing gum problems, whitening, anti-tartar and bad breath prevention.
By Jacky Li. Contact Cisema if you would like to learn more.