As a new type of foreign trade service provider driven by technological transformation and foreign trade business, HiSiaddi has established a "1+2+3+4=1" service system and can supply chitosan sourced from multiple well-known original manufacturers. With over a decade of market experience and consistent factory technological transformation collaboration, HiSiaddi possesses extensive experience addressing product compliance issues. Below is a case of resolving chitosan export compliance issues delivered by HiSiaddi.
Please contact HiSiaddi customer service for consultation on more chitosan product compliance issues.
The buyer is VitalCare GmbH, a leading mid-to-high-end dietary supplement enterprise based in Hamburg, Germany. Its products are sold in high-end German health pharmacies (DM), cross-border EU organic supermarkets, and private health institutions, specializing in fat-loss capsules and gastrointestinal health oral tablets. Raw materials must comply with four access standards: EU Novel Food Regulations, REACH registration, EU Veterinary Regulation (EU No 1069/2009) for animal-derived raw materials, and EP European Pharmacopoeia. The enterprise planned an annual procurement of 12 tons of pharmaceutical oral-grade chitosan and previously sourced raw materials from Northern European suppliers for a long time before shifting to Chinese procurement amid rising European local raw material prices.
The customer independently contacted two domestic chitosan manufacturers to finalize an initial trial order of 2.3 tons. After goods arrived at Hamburg Port, Germany, customs seized and detained the shipment due to four critical compliance violations, generating high port storage detention fees and overdue liquidated damages. Germany’s drug administration simultaneously suspended raw material filing reviews, stalling the new product launch schedule. Domestic manufacturers could only provide national standard quality inspection reports and lacked familiarity with the full EU compliance system, unable to supplement customs clearance documents. The customer fully entrusted HiSiaddi to coordinate full-chain compliance rectification, supplementary qualification certification, and customs clearance release.
EU Regulations (EU No 1069/2009, 142/2011) stipulate that chitosan derived from shrimp and crab shells falls under processed animal-derived products. Raw material production factories must complete registration on the EU third-country enterprise white list, and each batch of goods must be accompanied by EU-standard official veterinary health certificates issued by China’s customs-registered commodity inspection institutions. The original supplying factory failed to complete EU factory registration and lacked formal veterinary certificates, leading customs to directly rule raw material source control non-compliant.
Chitosan is a chemical substance regulated by EU REACH Regulations. Pharmaceutical oral-grade chitosan requires complete EU REACH full registration and full English 16-section SDS safety data sheets as well as substance exposure assessment reports. Domestic manufacturers only issued Chinese factory reports without REACH dossier documentation, making it impossible to file with Germany’s ECHA agency.
EU New Food Regulation (2015/2283) classifies chitosan for oral dietary use as a novel food raw material, requiring complete toxicology, toxicokinetics, and heavy metal safety dossiers issued by the European Food Safety Authority (EFSA). Without filing documents, the raw material cannot be used for production of dietary capsules. Domestic manufacturers only produced goods in compliance with China’s national food additive standard GB29946, without EU novel food filing documentation.
Germany’s drug administration mandates fully English COAs with indicators aligned with EP Pharmacopoeia (five mandatory indicators: deacetylation degree, endotoxin, heavy metals, residual protein, and microbial content). Original product labels lacked raw material source information, batch traceability codes, and EU warning markings, while quality inspection data only complied with Chinese national standards, missing pharmacopoeia indicators required for terminal product filing.
HiSiaddi established a special team consisting of EU regulatory specialists, commodity inspection liaisons, and factory technical rectification specialists. Drawing on resources of domestic compliant leading chitosan manufacturers, rectification was implemented in four phases: factory qualification filing → supplementary document preparation → product indicator rectification → overseas filing and registration.
Non-compliant original manufacturers were eliminated, and HiSiaddi coordinated leading brand factories holding EU registration numbers, ISO13485, and GMP pharmaceutical production qualifications. Factories were assisted in supplementing aquatic raw material traceability documents (fishing quarantine certificates, shrimp shell origin certifications), filing with China’s customs commodity inspection authorities, and completing EU third-country factory access registration to obtain official EU factory registration numbers. Simultaneously, applications for EU-standard veterinary health certificates matching the detained shipment batch information were submitted to local commodity inspection bureaus for German customs clearance verification.
1. Coordinate an EU local REACH Only Representative (OR) to supplement complete REACH full registration dossiers and substance safety assessment reports based on existing basic factory substance data;
2. Compile fully English 16-section SDS safety data sheets in compliance with EU CLP labeling regulations, and revise outer packaging labels to mark raw material sources, molecular formulas, risk warnings, EU responsible party information, and batch traceability codes to meet German customs label inspection requirements.
Coordinate CNAS-accredited third-party testing institutions to retest the full detained shipment in strict accordance with EP European Pharmacopoeia standards for all indicators: deacetylation degree, molecular weight, endotoxin, heavy metals (lead, arsenic, cadmium, mercury), residual protein, and total bacterial count. Chinese-English bilingual EP-standard COA quality inspection reports were issued, with test data uploaded to Germany’s drug administration product filing system.
Collate factory raw material traceability documents, toxicology test reports, and long-term stability test data, and cooperate with the customer’s local EU compliance law firm to submit pre-filing documentation for novel food raw materials to EFSA, obtaining pre-filing acceptance receipts to meet mandatory production filing requirements for dietary raw materials and eliminate risks of unmarketable terminal products.
1. Release of Detained Shipment: Full compliance documents were submitted to Hamburg Customs, Germany. After full verification of all qualifications, customs lifted the seizure of goods, enabling smooth customs clearance and delivery of the full 2.3-ton chitosan shipment. HiSiaddi coordinated shipping companies to apply for detention fee exemptions, helping the customer recover approximately EUR 3,200 in port storage penalties.
2. Small-Batch Verification: The customer conducted small-scale mass production using rectified compliant raw materials, with all raw material and finished product random inspections by Germany’s drug administration passing compliance reviews, enabling smooth completion of new product filing.
3. Annual Framework Contract Signing: The customer finalized an annual procurement contract of 12 tons, shipped in 8 evenly distributed monthly batches. HiSiaddi implemented standardized regular compliance control: pre-shipment review of four mandatory documents (veterinary certificates, REACH documentation, EP quality inspection reports, and labels) for every batch to ensure full compliance upon shipment and rapid customs clearance upon arrival at European ports.
① Smooth replacement of imported raw materials with domestic alternatives reduced procurement costs by 24% compared to Northern European suppliers, enabling timely full-channel launch of new products in German pharmacies with an additional EUR 360,000 in annual revenue from dietary capsules. Later, all chitosan procurement and compliance services for its Austrian and Czech subsidiaries were fully entrusted to HiSiaddi, expanding annual procurement volume to 17 tons. ② A standardized internal raw material access control system was established based on compliance documentation from this project, with HiSiaddi’s compliance audit standards adopted for all subsequent new raw material procurement to avoid risks of import detention.
Supported by complete EU compliance qualifications and implementation cases, cooperating factories opened up Germany’s high-end dietary raw material supply chain and subsequently secured designated supply orders from three mid-to-high-end health product enterprises in the Netherlands and Switzerland, achieving steady growth in export volume of pharmaceutical-grade chitosan.
Beyond pure product trade, HiSiaddi positions itself as a full-chain compliance service provider, bridging information gaps between domestic manufacturers lacking systematic understanding of EU segmented regulations and overseas high-end customers unfamiliar with Chinese raw material certification processes. It has formed a standardized full compliance service system for chitosan exports to the EU, resolving compliance pain points across four dimensions: factory qualification, documentation, product indicators, and overseas filing.
Most domestic chitosan manufacturers are familiar with Chinese national standards but lack systematic awareness of EU animal-derived regulations, REACH, Novel Food Regulations, and MDR medical device regulations, only capable of providing conventional domestic documents. Mid-to-high-end European and American pharmaceutical and dietary enterprises face stringent access regulations, with missing compliance documents of any type leading to port detention of goods or failed terminal product filing. Drawing on regulatory expertise and upstream qualified factory resources, HiSiaddi delivers one-stop resolution of compliance pain points across four dimensions: factory qualification certification, document preparation, product indicator rectification, and overseas filing, serving as a typical case of foreign trade securing high-end overseas customers via professional compliance services.
Please contact HiSiaddi customer service for consultation on more chitosan product compliance issues.
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