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.
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