As a new-type foreign trade service provider driven by technological transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply chondroitin sulfate sourced directly from multiple well-known original manufacturers. Endowed with over a decade of market experience rooted in technological transformation cooperation with manufacturers, HiSiaddi possesses extensive expertise addressing product compliance issues. Below is a case handled by HiSiaddi regarding chondroitin sulfate compliance challenges.
Should you require consultation on chondroitin sulfate product compliance issues, please contact HiSiaddi customer service.
The cooperating buyer is SWISSJOINT, a medical food company headquartered in Zurich, Switzerland. For 28 years, it has specialized in high-end medical joint preparations and hospital rehabilitation nutrition products distributed across Switzerland, Liechtenstein, and Austria. Its products are sold in rehabilitation departments of Swiss federal public hospitals, premium organic pharmacy chains in the Alps, and sports rehabilitation supply chains for Switzerland’s national ice and snow sports teams. All finished products are categorized as EU medical dietary foods, strictly complying with five mandatory compliance standards: European Pharmacopoeia (EP), German LFGB food access specifications, EU Animal Hygiene Regulation (EC) No 853/2004, TSE/BSE bovine spongiform encephalopathy control, and EU General Product Safety Regulation (GPSR). Low-cost feed-grade and untraced bulk chondroitin sulfate raw materials are rejected entirely. The group maintains stable annual procurement of 28 tons of pharmacopoeia-grade bovine-derived chondroitin sulfate exclusively for proprietary formula softgels, sustained-release tablets, and medical oral liquids – a typical high-standard mid-to-high-end purchaser distinct from low-volume low-price buyers with loose compliance thresholds.
Previously, the group sourced pharmacopoeia-grade shark-derived chondroitin sulfate from Northern European pharmaceutical manufacturers year-round. Constrained by tight local European raw material production capacity, cumulative 32% year-on-year raw material price hikes, and extended ocean delivery cycles of 120 days, the client launched a domestic Chinese raw material localization procurement project in 2025. It independently finalized a 6-ton trial order with three leading domestic chondroitin sulfate manufacturers. Prior to shipment, five systematic compliance failures emerged: missing EU animal source access qualifications, non-compliant EP pharmacopoeia CEP documentation, broken TSE/BSE raw material traceability records, absence of EU legal compliance representatives, and misclassified customs HS coding for declarations. Swiss local import freight forwarders explicitly notified the client that existing documentation could not pass Swiss customs entry verification, with high risks of full-container detention, return shipment, or destruction upon port arrival, estimating direct cargo losses exceeding EUR 92,000 and stalled new product launch schedules. The three supplying manufacturers could only provide basic domestic GMP and ISO22000 certificates, lacking expertise in detailed latest EU import regulations and unable to supplement special overseas access compliance documentation. Manufacturers’ compliance departments solely manage domestic production qualification filings without EU regulation coordination experience. After unproductive multi-party coordination, the client urgently entrusted HiSiaddi with full authority to coordinate full-process compliance rectification, document supplementary filing, and pre-shipment customs pre-audit work.
HiSiaddi’s compliance specialists coordinated with the client’s Swiss legal team, import customs brokers, and three domestic manufacturers to sort five customs-blocking compliance pain points against EU Regulations (EU) 2019/625 and (EU) 2016/355 governing highly refined animal-derived products, EDQM pharmacopoeia administration rules, and GPSR product safety regulations – all mandatory access thresholds for mid-to-high-end raw material imports into Europe:
EU regulations explicitly classify chondroitin sulfate for human dietary and medical food use as a highly refined animal-derived product. Raw material production facilities must complete registration with the European Commission’s Directorate-General for Health and Food Safety (DG-SANTE) and be included in the third-country compliant manufacturer white list to qualify for EU exports. The three cooperating manufacturers only held domestic food production filings without official EU factory registration, rendering them ineligible for Swiss customs recognition – the primary rigid barrier preventing cargo clearance. Manufacturers cited lengthy, cumbersome EU white list application procedures and absence of dedicated compliance staff for follow-up filings.
For the client’s finished products to complete Swiss pharmaceutical administration listing filings, raw materials must be accompanied by a Certificate of Suitability (CEP, formerly COS) issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM) to verify compliance with European Pharmacopoeia monograph requirements. The three manufacturers could only supply USP and national standard Certificates of Analysis; two lacked CEP application experience, while the third held an in-progress application without finalized certificates, with temporary certification timelines unable to align with original vessel schedules.
EU regulations mandate full traceability of bovine-derived chondroitin sulfate covering live animal slaughter raw material procurement, cartilage extraction, refining, and processing. Each batch must be accompanied by slaughterhouse quarantine certificates, live animal epidemic prevention documentation, full batch circulation ledgers, and official TSE/BSE risk-free declarations. Manufacturers only retained finished product factory inspection records, with upstream cooperating slaughterhouses lacking EU-recognized pre-slaughter and post-slaughter veterinary quarantine documentation, breaking traceability chains and violating EU animal source safety control requirements.
Under the new EU GPSR regulation, non-EU food raw materials circulated within EU territory must designate a locally qualified EU compliance representative. Representative information must be marked on customs declaration documentation and outer product packaging; Swiss customs directly reject entry filings without EC Rep registration records. Domestic manufacturers were unaware of this new regulation and had never partnered with EU local agency institutions.
Manufacturers generalized chondroitin sulfate declarations under the HS code for “food additives,” while Swiss customs assign dedicated regulatory codes for medical food pharmacopoeia-grade raw materials. Misclassification triggers customs targeted sampling inspection and cargo detention, requiring supplementary pharmacopoeia-grade product specifications and end-use supporting documentation for reclassification, invalidating all original filing documents.
HiSiaddi assembled a dedicated team of EU compliance registration specialists, pharmacopoeia filing consultants, import and export customs brokers, and animal source traceability auditors, formulating a three-step implementation roadmap aligned with Swiss local regulations and unified EU statutes: complete pre-shipment rectification and certification first, revise customs declaration documentation second, and arrange cargo shipment last. All five compliance barriers were resolved within 28 days.
HiSiaddi coordinated domestic customs animal and plant quarantine departments and EU commercial inspection institutions in China to organize factory workshop hardware audit materials, annual internal quality control review reports, and raw material control SOP documents for the three manufacturers. Yantai Dongcheng Pharmaceutical was selected as the primary supplying factory with optimal qualifications, with HiSiaddi assisting the factory to submit temporary entry filing applications to EU DG-SANTE alongside supporting documentation to obtain temporary customs clearance filing receipts enabling clearance of the current 6-ton batch. Parallel support was provided to launch formal white list registration procedures for the factory to secure long-term stable EU export qualifications moving forward.
Addressing unissued CEP certificates, HiSiaddi coordinated the factory to submit EDQM CEP in-progress acceptance receipts paired with full EP pharmacopoeia test reports from SGS EU-accredited laboratories and factory internal pharmacopoeia benchmarking inspection records, issuing official pharmaceutical manufacturer conformity statements. Swiss pharmaceutical administration pre-review confirmed the full set of equivalent documentation could temporarily support the client’s finished product listing filings prior to formal CEP certificate issuance. Simultaneous follow-up of the factory’s CEP application progress secured formal CEP certification three months later for inclusion in standardized future compliance documentation archives.
HiSiaddi assisted manufacturers in switching upstream slaughterhouses holding EU recognized registration status to secure bovine trachea raw material sources. Cooperating slaughterhouses issued EU-standard pre-slaughter and post-slaughter veterinary quarantine certificates and live animal epidemic prevention qualification documents, establishing full batch traceability ledgers covering live animal breeding → slaughter cartilage extraction → raw material factory intake → extraction & refining → finished product factory release. Batch-by-batch official TSE/BSE risk-free declarations were drafted, with all documentation reviewed and sealed by domestic entry-exit inspection and quarantine bureaus to meet EU animal source traceability inspection standards.
Leveraging long-term cooperative Swiss local compliance institutions, HiSiaddi contracted authorized EU EC Rep compliance representatives for manufacturers and completed EU enterprise system filings. Representative names, addresses, and registration numbers were marked synchronously on product outer packaging, commercial invoices, and packing lists alongside full sets of customs declaration documentation, supplementing product safety assessment reports mandated by GPSR regulations to fully resolve compliance gaps from absent representatives.
Coordinating with local Swiss customs brokers, HiSiaddi finalized precise HS coding for chondroitin sulfate per Swiss customs medical food raw material regulatory catalogs, revising product descriptions on contracts, invoices, and packing lists. Supplementary pharmacopoeia-grade specifications and medical food finished product end-use supporting documentation were compiled, with bilingual Chinese-English declaration documents cross-referenced and pre-audit filings completed with Swiss customs to eliminate compliance risks from misclassified declarations.
Following completion of all compliance documentation rectification, the 6-ton chondroitin sulfate batch was shipped from Qingdao Port to Zurich Port, Switzerland. Swiss customs conducted itemized verification of DG-SANTE filing receipts, equivalent CEP pharmacopoeia documentation, TSE traceability quarantine papers, EC Rep agency filing records, and standardized classified customs filing documents, passing full inspection in one go without detention or cargo return. Goods were delivered to the client’s Swiss production facility warehouse without incident. The client simultaneously utilized complete compliance documentation to complete Swiss pharmaceutical administration listing filings for new products, launching the previously delayed new product line onto premium Swiss pharmacy channels as scheduled. Full-item testing at third-party AENOR laboratories in Switzerland confirmed all raw material indicators complied with EP Pharmacopoeia and LFGB standards, with successful full-dosage-form pilot mass production of finished products.
Drawing on a fully established compliance system, the client formalized the full-year 28-ton annual procurement contract split into seven monthly production batches. HiSiaddi implemented a pre-delivery batch compliance pre-audit mechanism, completing documentation pre-review, traceability verification, and customs declaration pre-filing for all batches prior to factory release, with full archived compliance documentation supplied per shipment. Cost performance versus raw materials previously imported from Northern Europe: comprehensive procurement costs dropped by 27.3%, and ocean delivery cycles shortened from 120 days to 39 days, drastically optimizing supply chain costs and turnover efficiency.
1. SWISSJOINT Group of Switzerland fully terminated Northern European manufacturer procurement, shifting 100% of its annual 28-ton raw material sourcing to compliant domestic supply from China. A new annual procurement order of 10.8 tons for small-molecule chondroitin sulfate for children’s medical food was added the following year. HiSiaddi leveraged mature compliance systems established during this project to rapidly supplement complete compliance documentation for the new product line for cooperating manufacturers;
2. Drawing on full EU compliance delivery experience accumulated from this case, HiSiaddi assisted cooperating manufacturers to build standardized EU export compliance archives structured across five modules: DG-SANTE filings, CEP applications, TSE traceability, EC representative services, and customs coding classification standardized document templates, enabling manufacturers to successfully develop two peer mid-to-high-end medical food clients in Austria and Finland;
3. The client designated HiSiaddi as its official Chinese raw material compliance audit service provider, delegating pre-procurement compliance risk screening for all future raw material purchases (glucosamine, MSM, etc.) to eliminate entry hidden risks at the source.
Most domestic chondroitin sulfate manufacturers focus on domestic GMP and national standard production systems with proficiency in domestic food and pharmaceutical compliance requirements, yet generally lack research on medical food raw material regulations enforced in the EU, Switzerland, and other developed markets. They can only supply basic factory release qualification documentation with limited awareness of mandatory overseas compliance clauses including DG-SANTE white list filings, CEP pharmacopoeia certificates, full-chain TSE traceability, and EU representative requirements under GPSR regulations. Mid-to-high-end European medical food enterprises face dual stringent supervision from local pharmaceutical administrations and customs; raw material compliance constitutes a rigid precondition for product listing and cargo customs clearance. Independent manufacturer engagement often results in broken compliance documentation chains and missing qualifications, exposing buyers to massive cargo loss risks and stalled project timelines.
Breaking the traditional foreign trade model limited to raw material sourcing and quotation order taking, HiSiaddi specializes in researching dietary and medical food raw material regulations across global markets, delivering full-chain services covering manufacturer qualification rectification, overseas certificate agency filing, traceability system construction, and customs compliance optimization as a third-party compliance service provider. It helps mid-to-high-end European clients eliminate China procurement compliance barriers, avoid cargo detention and return shipment losses, and smoothly deliver domestic raw material substitution, while supporting premium domestic manufacturers to supplement high-end market access qualifications, escape homogenized low-price export competition, and successfully penetrate high-end European medical food supply chains – delivering long-term win-win outcomes for both supply and demand sides.
Should you require consultation on chondroitin sulfate product compliance issues, please contact HiSiaddi customer service.
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