As a new-type foreign trade service provider driven by dual engines of technology transformation and foreign trade services, HiSiaddi has built a "1+2+3+4=1" service system and can supply hyaluronic acid sourced directly from multiple well-known original manufacturers. As a R&D-oriented foreign trade service provider with over a decade of market experience, HiSiaddi has rich experience in handling product compliance issues through factory technology conversion cooperation. Below is a case of HiSiaddi addressing compliance problems for hyaluronic acid products.
Please contact HiSiaddi customer service if you wish to consult more compliance issues for hyaluronic acid products.
1. Partner Client: Eclat Lux High-End Salon Group based in Paris, France (authentic mid-to-high-end client). It specializes in light luxury medical repair serums, sterile post-aesthetic procedure dressings and high-end salon mesotherapy raw liquids. Its full-channel products are sold in over 180 private high-end medical aesthetics clinics and chain cosmeceutical department stores across France, Belgium and Monaco. Products comply with four mandatory EU regulations: EC1223/2009 Cosmetic Regulation, SCCS Safety Assessment, REACH Chemical Control and CPNP Raw Material Filing. The group purchases 28 tons of EP Pharmacopoeia-grade medical sodium hyaluronate annually in three major specifications: ultra-low molecular weight oligomeric HA, medium molecular weight injectable HA and high molecular weight cross-linked HA. It originally planned one-time container shipment from a leading domestic HA factory, yet the entire 12-ton cargo was detained upon arrival at Le Havre Port, France, unable to clear customs and facing risks of late storage penalties and delayed launch of end products.
2. Incident Background: The client directly purchased raw materials from domestic HA manufacturers, who could only provide Chinese national standard COAs and domestic production qualifications, lacking full sets of EU compliance documents. French customs inspection identified multiple compliance loopholes, detaining the full container of 12 tons of goods. Faced with stagnant new product launch plans, the client entrusted HiSiaddi foreign trade service provider with full authority to handle compliance rectification, customs clearance & release and long-term compliance filing.
3. HiSiaddi Positioning: Chemical raw material foreign trade compliance service provider coordinating upstream raw material factories, EU compliance institutions, third-party testing laboratories and EU local compliance responsible persons to fully supplement full-chain compliance documents in one stop, release detained goods and implement a long-term compliance system.
1. The annual EU import volume of this batch of hyaluronic acid exceeds 1 ton; per REACH regulation requirements, raw materials must complete EU entity registration with a unique REACH registration number. The supplying factory only completed domestic filing without HA monomer REACH registration certificates or pre-registration vouchers, leading customs to rule the raw materials unqualified for EU chemical market access and ban entry.
2. MSDS safety data sheets are Chinese national standard versions, not compiled into French-English bilingual SDS in accordance with EU GHS Version 6 regulations; impurity classification, storage & transportation risks and toxicology labeling fail to meet EU customs inspection specifications.
1. EU regulations require salon medical-grade HA to carry CPSR cosmetic safety assessment reports issued by SCCS-accredited laboratories, with missing full safety demonstration data for raw material heavy metals, protein residues, endotoxin and microorganisms. The factory’s original COA only marks national standard purity without test data for EU-limited pollutant thresholds (single heavy metal ≤0.1ppm, protein ＜0.01%, endotoxin ＜0.03EU/mg).
2. No raw material filing completed in the EU CPNP cosmetic notification system with no filing receipt code. EU regulations mandate filing declaration for all imported cosmetic raw materials before market entry; goods without filing will be detained.
1. EU regulations mandate designated legal persons holding certificates within the EU as compliance responsible persons (RP) for imported overseas raw materials. Neither the client nor domestic factory signed a French local RP institution in advance, leaving customs unable to confirm the subject of compliance accountability and directly detaining goods.
2. Missing complete PIF product information file, including GMP production audit documents, production process verification reports, three-batch stability test data and animal-test-free statements. PIF files are mandatory for random inspections by EU drug authorities, and missing items prevent customs release.
1. Outer carton labels only marked product names in Chinese, without the international universal INCI raw material name SODIUM HYALURONATE; batch numbers, production dates, shelf lives and EU RP addresses were incompletely marked, violating EU import label specifications.
2. The client’s products are used for post-aesthetic procedure dressings requiring raw materials to meet EP European Pharmacopoeia standards; the factory only provided Chinese Pharmacopoeia test reports without SGS foreign-language reports for full-item testing aligned with EP Pharmacopoeia, unable to support the client’s domestic drug filing in France.
1. HiSiaddi coordinates upstream raw material factories to liaise with domestic compliance institutions, retrieve authorized use letters for the factory’s filed HA REACH consortium registration, expedite issuance of registration association certificates corresponding to the batch for submission to French customs inspection. Pre-registration vouchers for remaining unregistered specifications are processed simultaneously to guarantee compliant shipment of subsequent batches.
2. Cooperate with EU compliance laboratories to recompile French-English bilingual MSDS/SDS per EU GHS standards, supplement toxicology data, hazard classification of impurities and storage & transportation safety instructions, and affix notarized seals from compliance institutions for customs clearance filing.
1. HiSiaddi liaises with EU SCCS authorized third-party testing laboratories (BV France) to collect retained samples of detained goods for expedited full-item testing covering heavy metals, microorganisms, endotoxin, protein residues and molecular weight distribution aligned with EP Pharmacopoeia, issuing French-English bilingual COAs + CPSR safety assessment reports meeting SCCS review standards.
2. Leverage cooperative French local compliance institutions (RP service providers) to complete online declaration of three HA specifications in the EU CPNP notification system via RP entity accounts, obtaining CPNP filing codes within 1 working day and submitting filing receipts to customs for retention.
1. HiSiaddi assists the client in signing a Paris-based certified compliance company as the EU statutory RP responsible person, supplementing RP name, address and filing numbers to outer packaging labels for label compliance rectification.
2. Collaborate with domestic production factories to organize complete PIF files: ① ISO22716/GMP production system audit certificates; ② Full fermentation & purification process verification documents; ③ Three-batch normal-temperature accelerated stability test reports; ④ EU-compliant animal-test-free statements. All documents are notarized and filed in Chinese, English and French to form complete PIF archives retained by RP for inspection.
1. Provide on-site warehouse guidance for reprinting compliant outer carton labels, uniformly marking INCI raw material names, batch numbers, shelf lives, RP enterprise information and origin, and re-warehousing goods for secondary inspection after packaging replacement.
2. Send samples to SGS for EP European Pharmacopoeia-aligned full-item test reports; all indicators meet the market access standards of French medical dressing raw materials, and documents are simultaneously provided to the client for domestic cosmeceutical product filing in France.
1. Goods Customs Clearance: After supplementing and submitting the full set of compliance documents to customs, the 12 tons of HA detained for 18 days are successfully released and cleared into warehouses, generating only minor detention fees and avoiding full-batch goods return losses. The remaining 16 tons are shipped from Shanghai to France in two subsequent batches with zero inspection and smooth customs clearance.
2. Long-Term Benefits for Client ① Three new products incorporating domestic HA (post-aesthetic repair serums and dressings) are successfully launched in French high-end medical beauty channels; comprehensive raw material procurement costs drop by 26% compared with original imported European raw materials. ② HiSiaddi builds a long-term compliance system for the client: annual pre-filing of raw materials via REACH, annual CPNP updates and permanent RP trusteeship, eliminating repetitive detention rectification processes for new additional purchases of cross-linked HA and HA derivatives.
3. Benefits for Domestic Upstream Raw Material Factory Supported by this full set of EU compliance documents from the French mid-to-high-end client case, the factory improves export compliance files for EP-grade HA and successfully expands to multiple European salon brand clients in Spain and Italy.
4. Service Accumulation for HiSiaddi A standardized EU compliance service process for hyaluronic acid is established: REACH registration → SCCS assessment → CPNP filing → RP trusteeship → PIF archiving, supporting long-term compliance trusteeship business for multiple mid-to-high-end European raw material clients.
Major domestic HA manufacturers excel in production and manufacturing yet generally lack full-chain EU compliance supporting capabilities, only able to provide domestic national standard qualifications. Mid-to-high-end European and American medical beauty skincare clients are strictly regulated by multiple EU regulations, with REACH, CPNP, SCCS and RP all mandatory requirements; independent procurement easily triggers cargo detention and port stagnation. Leveraging cross-border compliance resources, HiSiaddi resolves compliance loopholes from full-chain document certification, third-party testing and EU local qualification implementation, both salvaging the client’s loss of current goods and establishing a long-term compliant procurement channel, achieving a three-way win-win situation: clients reduce costs, factories expand overseas customers and service providers increase revenue.
Please contact HiSiaddi customer service if you wish to consult more compliance issues for hyaluronic acid products.
+86-13120989737 
info@hisiaddi.com 
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