Global Cosmetics Regulatory Compliance Dossier

1. United States: FDA MoCRA Compliance Architecture

Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetic manufacturers and brand owners face expanded federal oversight. YANSE COS assists your US entity across all required compliance tiers:

• FDA Facility Registration (Section 607): Fujian Yanse Cosmetics Co., Ltd. maintains active US FDA cosmetic establishment registration with an assigned FEI number, verified annually under Bureau Veritas US FDA Cosmetic GMP audits.
• Cosmetic Product Listing (Cosmetics Direct): We supply full quantitative ingredient breakdowns (INCI names with CAS numbers and exact percentage bands) to enable your US Responsible Person to complete federal product listings seamlessly.
• Safety Substantiation (Section 608): Every production formula undergoes accelerated stability testing (3 months at 40°C/75% RH, equivalent to 24–36 months ambient shelf life), USP 51 antimicrobial challenge testing, and USP 61/62 microbial enumeration.

2. European Union: Regulation (EC) No 1223/2009 & CPNP

Selling skincare in the EU/EEA and UK requires appointing an established EU/UK Responsible Person (RP) and preparing a comprehensive Product Information File (PIF) including the Cosmetic Product Safety Report (CPSR Part A & B):

• CPSR Part A Data Dossier: We compile the complete manufacturer package—heavy metal screening (Lead, Arsenic, Mercury, Cadmium <10ppm), microbiological specifications (<100 CFU/g), packaging compatibility data, and raw material purity certificates.
• Cosmetic vs Medical Device Boundaries: Our hydrocolloid acne patches and <300 μm dissolving microdarts are carefully documented under cosmetic appearance claims, preventing regulatory reclassification as medical devices.

3. Bureau Veritas & Factory Audit Verification Gateway

To protect buyers against fraudulent certificates, YANSE COS provides full transparency. You can verify our active credentials directly with certifying bodies: