The new Cosmetic Supervision and Administration Regulation (CSAR) introduces some major changes:
Classified management of new cosmetic ingredients based on risks
Applicants of products formulated with “higher risk new ingredients” (such as preservatives, sunscreens, colorants, hair dyes, whitening / freckle-removing agents) shall register with NMPA (National Medical Products Administration) and obtain approval. Registration application results will be given within 113 working days.
Other products formulated with 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.
The new system for filing management of products formulated with low-risk new cosmetic ingredients will significantly benefit the upstream cosmetics industry, ingredient, and fine chemical enterprises in China.
Cosmetic Products Classification
“Special Cosmetics” reduced to 5+1 Categories
In China, cosmetics are supervised as special and general cosmetics. The category of special cosmetics is reduced to 5+1 categories. Other cosmetics are general cosmetics.
|Previous Special Use Cosmetics||Current Special Cosmetics|
|Hair growth products||Hair dyes|
|Hair dyes||Hair perming products|
|Hair perming products||Freckle-removing /whitening products|
|Whitening products||Anti-hair loss products|
|Breast beauty 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 previous special cosmetics (hair growth, depilating, breast beauty, slimming, and deodorants) can be manufactured, imported, or sold during the 5-years transition period.
Toothpaste and Soap
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.
However, the 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.
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.
Support efficacy claims 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.
Wider Range of Penalties and Stricter Punishment
Multiple penalties. The penalties include warning, confiscation, fines, order to suspend production and operation for rectification, revocation of licenses, the prohibition in industry engaging, etc.
Refined 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.
Increased 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.
Punishment of 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.
Four subsidiary regulations
|Administrative Measures on Cosmetic Registration (Draft for Comments)||It clarifies the basic requirements for registration and filing management of cosmetics and new cosmetic ingredients, including some new concepts, patent protection for the new ingredients, ingredient traceability management, cosmetic efficacy claims, annual reporting, etc.|
|Cosmetics Manufacture and Operation Supervision and Management Measures (Draft for Comments)||It details the production license management, production quality management, operation quality management, network operation management, and legal responsibilities.|
|Technical Guidelines for Cosmetic Safety Assessment (Draft for Comments)||The draft guidelines clarify the basic requirements of safety assessors, the requirements and operating guidelines for safety assessment reports, attach corresponding samples and set transitional measures to ensure a smooth transition.|
|Cosmetic Classification Rules and Catalog (Draft for Comments)||The draft lists 28 efficacy claims, 13 application areas, 14 dosage forms, 3 types of target users and 2 application methods to determine the classification of cosmetics.|