Regulations on the supervision and administration of cosmetics
The latest version of this document has been submitted by the NMPA to the State Council for approval.
The regulation was formally approved by the State Council executive meeting on January 3, 2020.
Although the State Council has approved the draft, the NMPA has not formally issued the “Regulations”. At present, the “Regulations” are still in the implementation stage. The specific implementation time has not yet been determined therefore the regulatory requirements for cosmetics and raw materials in China still refer to the old regulations.
Article 4: Oral care products included in the cosmetics list
The original definition of cosmetics did not include oral care products. After examining foreign regulations such as United States, EU, Japan and other countries, NMPA decided to include oral care products in cosmetics management. After the implementation of the new regulations, oral care products such as toothpaste and mouthwash will be recorded and managed in accordance with non-special-purpose cosmetics.
Articles 9 & 10: Management of new ingredients
Approval and filing
- Approval and filing are carried out according to risk categories. Simplified procedure for approval of low risk ingredients
- Preservatives, sunscreens, colorants, hair dyes, whitening agents, and high-risk raw materials are submitted to the administrative license for approval in accordance with the administrative requirements for new cosmetic raw materials
- Other common raw materials are filed in accordance with the filing requirements (faster and easier than administrative approval). The specific regulatory requirements for the filing of common raw materials still need to be promulgated and implemented by the NMPA
Timing for approval and filing of new ingredients
Common ingredients: Filing (30 working days) + pubblication (10 working days) + report on situation on the market (3 years).
Special use ingedients: Submission of administrative license approval (time to be determined) + report on situation on the market (3 years).
Old Vs New
In the old regulation all new ingredients (including domestic and imported) needed to be submitted for administrative approval. After the implementation of the new regulations, domestic raw materials and imported raw materials only need to be uniformly evaluated according to safety. High-risk raw materials will still be subject to administrative license approval. Low risk ingredients will just need filing.
Articles 11-20: redefinition of special use cosmetics + domestic and imported non SUC products
Redefinition of Special use cosmetic products
The new regulation includes in the special use cosmetic products category only 4 categories of products: hair dyeing, perm, whitening / freckle, sun protection + other cosmetics that the CFDA believes require special management. The special categories of bodybuilding, deodorization, hair growth, and hair removal products have been removed.
These latter products may follow General categories and undergo just the filing procedure. However, the CFDA has reserved its opinion and clarified that there may be “other cosmetics that require special management” as considered by the regulatory authorities, so the scope of special cosmetics categories may be dynamically adjusted after the implementation of new regulations in the future. Validity period of special category registration certificate extended to 5 years.
Timing for approval and filing
Common cosmetic product: Domestic products report to the province (10 working days); imported products report to NMPA (10 working days).
Special use cosmetic products: testing (confirmed by testing agency according to different product categories at specific time) + NMPA approval (120wd ~ 150wd), the specific approval process includes: NMPA acceptance (1week) + NMPA technical review (90wd) + NMPA final approval (20wd).
Article 44: mandatory efficacy claims validation
The new regulations require that there be sufficient scientific basis for the claims of cosmetic efficacy, and relevant verification materials must be made public on the NMPA-designated website and accept social supervision. This regulation obliges cosmetic companies to consciously perform the product’s claimed efficacy evaluation.