Regulatory Framework
China regulates cosmetics through the CSAR framework and its supporting rules, including filing, registration, labelling, safety assessment, and ingredient information requirements. Ordinary imported cosmetics generally require pre-market filing, while special cosmetics such as sunscreen, hair dye, perm, anti-hair-loss, spot-correcting, or new efficacy categories require registration before launch.
Cosmetic Definition
Daily-use chemical products applied to the surface of the human body, such as skin, hair, nails, or lips, by rubbing, spraying, or similar methods for cleansing, removing undesirable odours, skincare, beautification, or adornment purposes.
Responsible Person Requirements
An overseas registrant or filer must appoint a China-established Domestic Responsible Person. That entity supports filing or registration, adverse event monitoring, recall coordination, communication with the authorities, and joint responsibility for product quality and compliance in the China market.
Compliance Process
- Account Access and Entity Onboarding
- Set up the NMPA filing environment under the Domestic Responsible Person and link the overseas manufacturer and brand owner materials.
- Prepare quality-system evidence, authorization documents, and notarized or legalized materials where required.
- Technical Submission Package
- Prepare the full formula with INCI, China standard names, concentration data, and ingredient safety information references.
- Prepare product standards, artwork, 3D pack visuals, and the Chinese label package required under current rules.
- Prepare the production process summary and any route-specific declarations.
- Testing and Safety Assessment
- Coordinate route-appropriate testing, including whether current rules allow a reduced toxicology package for the product type.
- Prepare the safety assessment package according to the current China safety assessment requirements and category expectations.
- Filing or Registration Outcome
- For ordinary cosmetics, complete the filing process and publication requirements before import sales.
- For special cosmetics, track the registration review through approval before launch.
China now expects the full-form safety assessment approach under the current framework, and ingredient management must also be checked against the Inventory of Existing Cosmetic Ingredients in China.
Deliverables
- China route classification between filing and registration
- Domestic Responsible Person onboarding support
- Formula review and ingredient safety information alignment
- Chinese artwork and label drafting review
- Testing and safety assessment dossier coordination
- Full-cycle NMPA filing or registration support
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