Key Points in China Cosmetic Supervision and Administration Regulation (CSAR)

On June 29, 2020, China State Council finalized the Cosmetics Supervision and Administration Regulation (CSAR) and will implement it on Jan 1, 2021 ^[1]. This article will sort out the key points of the new CSAR.

1. Classified Management of New Cosmetic Ingredients Based on Risks

1) Filing Management of Low-risk New Cosmetic Ingredients

New cosmetic ingredients with higher risk new ingredients such as preservatives, sunscreens, colorants, hair dyes, whitening/freckle-removing agents shall register with NMPA and obtain approval. Registration application results will be given within 113 working days.
Other new ingredients shall file with NMPA before use. The filing is deemed to be completed after submitting the required filing documents through the online governmental affairs service platform of the NMPA.

Documents Necessary for New Cosmetics Ingredients Registration/Filing

1. Name, address and contact information of registration applicant or filer;

2. R&D report;

3. Research materials on manufacturing process, stability, and quality control standards;

4. Safety assessment dossiers.

The new system for filing management of low-risk new cosmetic ingredients will significantly benefit the upstream cosmetics industry, ingredient, and fine chemical enterprises ^[2].

2) Post-market Surveillance of Registered/Filed New Cosmetic Ingredients

Annual report

Registrants and filers shall report the use and safety data of the new ingredients to the NMPA annually. Within three years after the registered and filed new cosmetics ingredients are put into use, ingredients without safety issues will be included in the Inventory of Existing Cosmetic Ingredients in China (IECIC). Before the registered and filed new cosmetics ingredients are included in the IECIC, they shall still be managed as new cosmetics ingredients.

For enterprises that have completed the registration/filing of new cosmetic ingredients, they can use this ingredient within the three years observation period. For other enterprises, this ingredient still cannot be used in finished products within the three-year observation period.

Safety re-assessment

Where there is a change occurring in the understanding of the safety of cosmetics and cosmetics ingredients with the development of scientific research, or there is evidence showing that the cosmetics and cosmetics ingredients pose new risks, the medical products administration departments may organize safety re-assessment.

If the re-evaluation results show that cosmetics and cosmetics ingredients' safety cannot be guaranteed, the registration shall be revoked, or the filing shall be canceled. In addition, such cosmetics ingredients shall be included in the list of prohibited ingredients.

2. Cosmetic Products Classification

1) Special Cosmetics Reduced to 5+1 Categories

Cosmetics are supervised as special and general cosmetics. The category of special cosmetics is reduced to 5+1 categories. Other cosmetics are general cosmetics.

Current Special Use Cosmetics	Future Special Cosmetics
Hair growth products Hair dyes Hair perming products Depilating products Whitening products Breast beauty products Slimming products Deodorants Freckle-removing/whitening products Sunscreens	Hair dyes Hair perming products Freckle-removing/whitening products Sunscreens Anti-hair loss products Cosmetics claiming new efficacy

The definition of cosmetics claiming new efficacy may refer to the cosmetics classification rules/catalog to be released later. In the future, cosmetics will be classified according to the efficacy claims, application parts, product dosage forms, and applicable people, etc. Cosmetics not in the classification rules/catalog will be defined as cosmetics with new efficacy.

A transition period of 5 years is set starting from Jan 1, 2021. The previously registered special cosmetics, hair growth, depilating, breast beauty, slimming, and deodorants can be manufactured, imported, or sold during the 5-years transition period.

2) Toothpaste and Soap Management

Toothpaste

Toothpaste shall be managed with reference to the provisions on general cosmetics. After toothpaste filers conduct the efficacy evaluation in accordance with national standards and industry standards, efficacy such as anti-caries, plaque inhibition, anti-dentine hypersensitivity, and relieve gingiva problems, etc. can be claimed. Specific administrative measures for toothpaste are going to be released later.

Soaps

CSAR does not apply to soaps, excluding those claimed to have special cosmetics efficacy. For example, soaps with whitening efficacy shall be classified as special cosmetics.

3. Cosmetics Registrants and Filers

CSAR clarifies that cosmetic registrants and filers shall be responsible for cosmetics quality, safety, and efficacy claims.

Cosmetic registrants and filers shall:

Establish a quality management system.
The person in charge of quality and safety shall have professional knowledge related to cosmetics quality and safety, and more than five years of experience in cosmetics production or quality and safety management.
Possess the ability to monitor and evaluate adverse reactions.
Efficacy claims shall be supported by a sufficient scientific basis, and be disclosed on the NMPA website.
Conduct a safety assessment. Personnel engaged in safety assessment shall possess professional knowledge related to cosmetics quality and safety, and have more than five years of professional experience.
Establish a product recall system.

4. Wider Range of Penalties and Stricter Punishment ^[3]

1) Multiple penalties. The penalties include warning, confiscation, fines, order to suspend production and operation for rectification, revocation of licenses, not accepting the registration/filing application, the prohibition in industry engaging, etc.

2) Refine legal liability requirements. The circumstances of administrative penalties are specified. Newly add legal liability for submitting false documents for registration and filing, centralized market operators’ and e-commerce platform operators’ illegal activities, etc.

3) Increase the fines. The base of fines is adjusted from the illegal income to the value of the goods. Serious violations involving quality and safety can be fined up to 30 times the value of the goods.

4) Punishment to the main responsible person. According to the nature and seriousness of the illegal activities, fines, and penalties for prohibiting engaging in cosmetics production and business activities shall be imposed on the main responsible person.

5. E-commerce Platforms and Beauty Hairdressing Institutions are Under Supervision

1) E-commerce platforms

Operators of e-commerce platforms shall:

Register the real-name of the cosmetics operators on the platform
Assume the management responsibilities of cosmetics operators
To find any cosmetics operators on the platform who violate the provisions, the e-commerce platform operator shall promptly stop them and report to the medical products administration departments.
In case of serious violations, it shall immediately stop providing e-commerce platform services to illegal cosmetics operators.

2) Beauty and Hairdressing Institutions

Where beauty and hairdressing institutions, hotels, etc. use cosmetics in their operations or provide consumers with cosmetics, they shall fulfill the obligations of cosmetics operators.

Related Resources:

News 1: China Finalized the Long-Awaited Cosmetic Supervision and Administration Regulation
News 2: Finalization of CSAR: A Milestone on Road to Modernization of China’s Cosmetic Sector
Webinar (English/Japanese/Korean language): Interpretation of China's Cosmetic Supervision and Administration Regulation (Final Version)
English/Japanese/Korean Translation: Cosmetic Supervision and Administration Regulation
Featured Page: Catch the Significant Moments | China Cosmetic Regulatory Reform Tracking