HiSiaddi is an innovative foreign trade service provider driven by dual engines of technology commercialization and foreign trade services. We have established a "1+2+3+4=1" service system and can supply raw materials of sodium hyaluronate from multiple well-known original manufacturers. With over a decade of market experience and technological cooperation with manufacturers, HiSiaddi possesses extensive expertise in product compliance issues. Below is a case handled by HiSiaddi regarding compliance problems of sodium hyaluronate.
If you need consultation on more compliance issues of sodium hyaluronate products, please contact HiSiaddi customer service.
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Partner Client: Luxderma SAS, France A local French mid-to-high-end enterprise specializing in dermatological medical repair stock solutions, post-aesthetic dressings and high-activity salon serums sold at high-end medical aesthetic clinics and cosmeceutical chains in France, Belgium and Luxembourg. Its products comply with EU EC1223 cosmetic regulations, REACH chemical regulations, SCCS safety assessment standards and the European Pharmacopoeia (EP). The annual planned procurement volume is 22 tons of dual-grade medical & cosmetic sodium hyaluronate (divided into three specifications: oligomeric low molecular weight, high-purity medium molecular weight and high molecular weight film-forming). The client previously independently sourced raw materials from a major domestic HA manufacturer. After production completion and pending shipment, multiple compliance bottlenecks emerged, with pre-audit warnings from French ports indicating high risks of full-container detention and return. The client urgently entrusted HiSiaddi to fully manage full-chain compliance rectification.
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Pre-Procurement Hidden Risks for the Client (Manufacturers Only Provide National Standard Documentation Without Familiarity With EU Access Regulations) The client selected a major domestic HA manufacturer for sampling and mass production. The factory could only issue national standard COAs and domestic production qualifications, unable to provide mandatory EU import compliance documentation. Unfamiliar with EU raw material access rules, the client discovered four critical compliance flaws shortly before shipment, leaving goods stranded in Shanghai bonded warehouses unable to clear customs: ① Missing EU REACH pre-registration documents and no EU-based Responsible Person (RP); ② Raw material COAs follow domestic laboratory standards without full testing per EP standards and EU limit values. Report formats for heavy metals, endotoxins and protein indicators are unrecognized by French customs; ③ Missing supporting raw material files for CPSR safety assessments, making EU CPNP raw material notification impossible; ④ Outer packaging labels fail to adopt the INCI international raw material nomenclature. Mandatory labeling items including raw material source, batch traceability and storage warnings are non-compliant with French import label inspection requirements.
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Positioning of HiSiaddi’s Services A cross-border compliance & foreign trade service provider linking EU compliance laboratories, EU licensed toxicologists, upstream manufacturers and local French compliance agents to complete compliance documentation item by item, rectify products and files, and guarantee smooth customs clearance of goods.
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EU regulations clearly stipulate that cosmetic raw materials entering EU territory must complete REACH pre-registration, and importers must appoint a licensed EU-based Responsible Person (RP). Goods without RP filing or complete REACH dossiers will be directly detained and returned upon arrival, incurring high port storage fees and disposal risks. Neither the client nor the supplier factory completed REACH registration in advance or signed a local French RP agent.
The factory’s original COAs were compiled per Chinese national standards with missing test items for heavy metals (lead, arsenic, cadmium, mercury), free protein, bacterial endotoxins, solvent residues and molecular weight distribution. Limit values exceed EU access standards. French customs only accepts batch COAs issued by EU CNAS-accredited laboratories in accordance with EP standards. Original reports cannot be used for compiling the client’s CPSR safety reports, and raw materials cannot be entered into the CPNP notification system.
EU EC1223 regulations require all cosmetic raw materials to complete online CPNP notification prior to market launch, supported by complete PIF product information files and CPSR toxicological safety assessment reports. CPSR requires full raw material toxicological data, microbial stability reports and GMP production statements. Upstream manufacturers cannot provide EU-format toxicological dossiers, and the client’s R&D department lacks raw material compliance data to complete finished product safety filing, preventing terminal product launch in France.
Product outer packaging only bears Chinese plus simple English product names without the international INCI name for HA (SODIUM HYALURONATE). Mandatory labeling items including fermentation source of raw materials, production batch numbers, shelf life, storage conditions, sensitization warnings and traceable QR codes are missing. Pre-inspection of labels by French customs directly identifies non-compliant labeling.
1. HiSiaddi coordinated EU compliance institutions to organize data including raw material CAS number, production processes, physicochemical parameters and annual output, completing REACH pre-registration for sodium hyaluronate within the time limit and issuing official registration dossiers;
2. Assisted the client in signing a licensed compliance institution in Paris, France as the statutory EU RP responsible person, completing RP information filing in EU pharmaceutical supervision systems. RP information was incorporated into all subsequent customs clearance and notification documents to eliminate core customs detention risks.
1. HiSiaddi coordinated upstream manufacturers to retain samples of corresponding batches and send them to third-party testing laboratories with EU qualifications in China for full retesting strictly in accordance with the European Pharmacopoeia (EP) and EU cosmetic raw material limit standards: single heavy metal element ＜0.1ppm, free protein ＜0.01%, endotoxin ＜0.1EU/mg, raw material purity ≥99.5% (cosmetic grade) / 99.9% (medical grade);
2. Bilingual Chinese-English standardized COAs were issued by EU-accredited laboratories, marking EP testing methods, batch numbers and raw material specifications with official laboratory seals, directly applicable to French customs clearance and the client’s CPSR compilation.
1. Cooperated with manufacturers to organize GMP production statements for Class 10,000 clean workshops, strain source certificates, full-process production technical documents and 24-month batch stability test data;
2. Connected licensed EU toxicologists to compile segmented raw material safety dossiers based on new COAs and full raw material data, supplementing toxicology test summaries. Supported by compliant raw material dossiers, the client was assisted in completing online CPNP EU cosmetic raw material notification and obtaining official notification receipts, enabling the client to compile finished product CPSR safety assessment reports and complete domestic French product launch filing normally.
1. HiSiaddi issued an EU label specification checklist and guided manufacturers to reprint inner and outer packaging: uniformly adopt the standard INCI name SODIUM HYALURONATE; add microbial control reminders, storage temperature & humidity, raw material source (microbial fermentation), batch traceability QR codes and PAO open shelf life labels;
2. Sample labels of full containers were pre-reviewed by HiSiaddi before sealing to eliminate risks of unqualified label inspection upon entry.
1. Closed-Loop Document Verification: All compliance documents (REACH dossiers, RP filing certificates, EP-compliant COAs, CPNP receipts, full PIF dossiers, label audit forms) were compiled into bound files, with electronic copies submitted to French customs for pre-inspection, which passed in one round, revoking the original detention warning.
2. Batch Shipment & Customs Clearance: 22 tons of HA were shipped in 5 containers from Shanghai Port to Le Havre Port, France. Upon arrival, French customs conducted on-site sampling inspection of raw material physicochemical indicators and cross-checked full documentation. All batches cleared customs smoothly with no port detention or fines.
3. Terminal Finished Product Launch: The client used compliant raw materials to complete mass production of three salon serums and post-operative dressings. Supported by complete CPSR reports, all finished products passed launch filing with French pharmaceutical authorities and were listed across over 210 high-end medical aesthetic clinics in France as scheduled.
1. Avoided losses from full-container goods return (goods value exceeding 1.2 million EUR), saving approximately 180,000 EUR in port storage, reallocation and return-related costs. Comprehensive procurement costs of domestic HA decreased by 29% compared to original European imported raw materials, and annual revenue from newly launched products increased by 35%. The client renewed an annual procurement order of 28 tons the following year and added customized procurement demand for cross-linked hyaluronic acid.
Supported by full EU compliance rectification experience from this project, the factory improved EP-grade HA pre-delivery documentation systems and standardized document templates for REACH and EU COAs. Multiple mid-to-high-end European cosmeceutical clients in Italy and Switzerland were successfully developed thereafter, achieving a 25% export premium for high-end grades.
A standardized EU HA raw material compliance service system covering REACH registration, RP contracting, EP testing, CPNP notification and label rectification across the full chain was established. Supported by this benchmark French case, the company deepened penetration into mid-to-high-end medical aesthetic raw material markets in Western Europe, securing subsequent similar compliance supporting orders from Spain and Germany.
Domestic HA manufacturers excel at production per national standards yet generally lack familiarity with multi-dimensional EU cosmetic and chemical regulations. Overseas mid-to-high-end cosmeceutical brands focus on terminal formula development without understanding China’s raw material pre-delivery compliance documentation systems, easily encountering compliance bottlenecks after mass production. Supported by cross-border compliance resources, HiSiaddi resolves full-dimensional import compliance challenges covering regulatory filing, testing rectification, dossier compilation and label standardization, eliminating losses from goods detention and scrapping. A three-way win-win outcome was realized: overseas brands achieved stable localized procurement of domestic raw materials, domestic manufacturers expanded high-end overseas channels, and the service provider generated increased revenue via value-added compliance services.
If you need consultation on more compliance issues of sodium hyaluronate products, please contact HiSiaddi customer service.
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info@hisiaddi.com 
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