Enterprise E-E-A-T & Quality Engineering
Regulatory Certifications & Quality Assurance
Beautychain Limited operates dedicated cleanroom cosmetic manufacturing facilities certified to international standards. We supply turnkey OEM/ODM lip cosmetics fully compliant with US FDA MoCRA and European Union Cosmetics Regulation (EC) No 1223/2009.
Standard No. ISO 22716:2007
Audited CleanroomISO 22716 Cosmetics GMP Certification
Our production lines adhere strictly to ISO 22716:2007 Good Manufacturing Practices for Cosmetics. Covering personnel, premises, equipment, raw material quarantine, hygienic batch processing, packaging, and laboratory quality control.
- Class 100,000 (ISO Class 8) HEPA-filtered cleanroom filling suites
- Dedicated HVAC differential pressure controls preventing cross-contamination
- Automated CIP (Clean-in-Place) stainless steel batch emulsification vessels
- Full traceability from raw material lot to finished boxed SKU
US FDA Standard
FDA CompliantUS FDA GMPC (US Guidelines)
Fully compliant with the United States Food and Drug Administration's Good Manufacturing Practice guidelines for cosmetics (CFSAN 21 CFR Part 700/701).
- Continuous environmental microbial air sampling and surface swabbing
- Validated DI (Deionized) reverse osmosis water purification systems
- Double-barrier airlock personnel sanitation protocol
- Strict retention sample archiving for 36 months post-batch release
Global Regulatory Readiness
Turnkey Dossiers for USA & European Distribution
Exporting cosmetics requires airtight documentation. We provide complete technical dossiers directly to your designated Responsible Person (RP) or regulatory agent.
United States — FDA MoCRA Compliance
Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA):
- Facility Registration (Section 607): Beautychain manufacturing facilities are registered with FDA FEI credentials.
- Cosmetic Product Listing (Section 607): Complete formula breakdowns and quantitative INCI listings provided for fast FDA portal submission.
- Safety Substantiation (Section 608): Toxicological profile reviews, batch stability records, and ingredient purity records.
- Adverse Event Recordkeeping: Standardized logging procedures adhering to FDA audit standards.
European Union & UK — CPNP Notification
In strict compliance with EU Regulation (EC) No 1223/2009 and UK Schedule 34:
- CPSR Dossier Ready: Cosmetic Product Safety Report Part A and Part B prepared by qualified European toxicologists.
- CPNP Portal Notification: Full assistance with EU CPNP and UK Submit Cosmetic Product Notification (SCPN).
- Cruelty-Free / Animal Testing Ban: 100% compliant with EU Chapter V animal testing prohibitions. Alternative in-vitro testing only.
- Annex II & III Compliance: Zero banned substances, strictly approved colorants and preservatives.
Laboratory Protocol
Standard Release Testing Limits (Every Production Batch)
Every production run is backed by a Certificate of Analysis (COA) issued by our internal QC lab and verified via third-party testing (SGS / Intertek upon request).
| Test Category | Testing Parameter | Specification / Limit | Test Methodology |
|---|---|---|---|
| Heavy Metals | Lead (Pb) | ≤ 10 mg/kg (ppm) — typically < 2 ppm | ICP-MS (Inductively Coupled Plasma Mass Spectrometry) |
| Heavy Metals | Arsenic (As) | ≤ 2 mg/kg (ppm) — typically < 0.5 ppm | ICP-MS |
| Heavy Metals | Cadmium (Cd) | ≤ 5 mg/kg (ppm) — typically < 0.5 ppm | ICP-MS |
| Heavy Metals | Mercury (Hg) | ≤ 1 mg/kg (ppm) — typically < 0.1 ppm | Cold Vapor Atomic Absorption (CV-AAS) |
| Microbiology | Total Aerobic Microbial Count (TAMC) | ≤ 100 CFU/g (Lip mucosal standard) | ISO 21149 Plate Count Method |
| Microbiology | Total Combined Yeast and Mold (TYMC) | ≤ 10 CFU/g | ISO 16212 Plate Count Method |
| Microbiology | Specified Pathogens (E. coli, S. aureus, P. aeruginosa, C. albicans) | Absence in 1.0 g sample | ISO 22718, ISO 22717, ISO 21150, ISO 18416 |
| Physical Stability | Thermal & Freeze-Thaw Cycling | Zero syneresis, oil separation, or crystallization (-10°C to +45°C / 12 wks) | Accelerated Climatic Chamber Stability Protocol |
Enterprise Assurance
Need Specific Compliance Documentation for Your Retailer?
Whether you are pitching Sephora, Target, Ulta, or European pharmacy chains, our technical compliance team provides custom dossier packages, ingredient disclosure statements, and laboratory COAs.
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