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Yes, most require product notification filing with local health authorities before import and sale.
In general, a Product Information File (PIF), ingredient list, safety assessment, labelling, and packaging samples.
Cosmetic products in China follow two distinct regulatory pathways based on product type and function:
General Cosmetics Filing:
• Applicable Products: Standard cosmetic products including shampoos, lotions, makeup, and basic skincare
• Regulatory Process: Filing through the National Medical Products Administration (NMPA) electronic system
• Timeline: Processing typically completed within 2-3 months
• Documentation Requirements: Product formulation details, safety assessment reports, effectiveness claims support, and quality control standards
• Testing Requirements: Product quality testing and safety assessment without mandatory animal testing for qualifying products
• Post-Approval: Products receive a filing certificate with a unique identification number required on packaging
Special Cosmetics Registration:
• Applicable Products: Products with specialized functions including hair dyes, sunscreens, whitening products, anti-hair loss, and deodorants
• Regulatory Process: Formal registration and approval through NMPA with more stringent review
• Timeline: Review periods typically extend to 8-12 months
• Documentation Requirements: More extensive than general cosmetics, including comprehensive safety data and efficacy testing results
• Testing Requirements: More rigorous testing protocols, potentially including animal testing unless qualifying exemptions apply
• Post-Approval: Registration certificate with 5-year validity requiring renewal
Key factors determining the appropriate pathway include ingredient composition, product claims, and intended functions. Products making functional claims automatically require the special cosmetics registration pathway regardless of formulation.
The complexity of this process often results in extended timelines and significant resource investment. Common challenges include differences in testing standards between China and other markets, translation issues in technical documentation, and evolving regulatory requirements.
Knudsen & CRC manages the entire new ingredient registration process for cosmetic brands, leveraging specialized expertise in Chinese regulatory requirements. Our technical team prepares comprehensive documentation, arranges required testing with NMPA-approved laboratories, and maintains ongoing communication with regulatory authorities throughout the review period. This strategic approach has achieved registration approval for innovative ingredients that initially faced regulatory challenges.
EU cosmetic compliance requires adherence to Regulation (EC) No 1223/2009, with several critical components:
Under China’s Decree 248 (effective January 2022), all overseas food manufacturers must register with the General Administration of Customs China (GACC) before exporting to China. The required documentation varies based on product category:
All documents must be submitted in Chinese or with certified Chinese translations. High-risk category registrations must be submitted through the competent authority of the exporting country, while standard categories can self-register through GACC’s online system.
Substantiating cosmetic claims in China requires specific types of evidence that meet the National Medical Products Administration (NMPA) requirements:
International supplement brands can legally enter the Chinese market through two primary regulatory pathways:
The program involves a comprehensive regulatory strategy that leverages specific pathways in Chinese regulations that don’t require animal testing. This includes:
General Import Filing Pathway:
• For qualifying general cosmetics, the filing process can be completed without triggering mandatory animal testing requirements
• Products must meet specific formulation and safety documentation standards to qualify
• Good Manufacturing Practice (GMP) certification is required for manufacturing facilities
• Safety assessment must be conducted by qualified safety assessors
Cross-Border E-Commerce Channel:
• Allows limited market access without standard registration requirements
• Products sold directly to consumers through approved platforms
• Exempt from pre-market animal testing requirements
• Limited to specified transaction values and quantities
Key Compliance Requirements:
• Comprehensive safety assessment documentation using non-animal testing methods
• Manufacturing facilities must meet Chinese regulatory standards
• Implementation of rigorous post-market surveillance systems
• All product documentation must satisfy Chinese authorities’ requirements without triggering animal testing
Brands must carefully manage both pre-market compliance and post-market surveillance to maintain cruelty-free status while selling in China. The regulatory framework continues to evolve, with China increasingly accepting alternative testing methods for certain product categories.
A critical challenge in this process is navigating China’s unique technical requirements and communication with regulatory authorities. Knudsen & CRC’s specialized team has successfully registered diverse medical devices across all classifications, achieving approval times averaging 40% faster than industry standards through strategic pre-submission assessment and established relationships with testing laboratories.
If you still have more questions, contact us at info@knudsencrc.com and we’ll be sure to get back to you