HiSiaddi is an innovative foreign trade service provider driven by dual engines of technology transformation and foreign trade services, with a "1+2+3+4=1" service system and direct access to silymarin extract raw materials from multiple well-known original manufacturers. Boasting over a decade of market experience and technological transformation cooperation with manufacturers, HiSiaddi holds extensive expertise in product compliance issues. Below is a case of HiSiaddi addressing compliance challenges for silymarin extract.
If you wish to consult more compliance issues concerning silymarin extract products, please contact HiSiaddi customer service.
The cooperating purchaser is Sanamed GmbH based in Munich, Germany, a local mid-to-high-end dietary and specialist pharmaceutical enterprise specializing in prescription-grade liver-protecting soft capsules and premium organic oral liquids. Its products are sold nationwide at high-end German chain pharmacies, private wellness hospitals, and organic supermarkets in Austria and Switzerland. Raw materials must comply with six compliance systems: EU EC396 standard covering 226 pesticide residue items, REACH Chemical Regulation, EU 1169 Labelling Regulation, EU 2021/1317 Heavy Metal Limit Standard, LFGB Food Contact Regulation, and EFSA Health Claim Specifications. Annual planned procurement volume of medicinal-grade silymarin extract totals 22.3 tons, with mandatory indicators: silymarin ≥80%, silybin ≥30%, no exogenous filler excipients, and all raw materials used for end-product market filing.
The client previously sourced domestic German raw materials for years but launched its first procurement of Chinese silymarin extract amid European raw material price hikes and capacity shortages, independently selecting two leading domestic plant extract manufacturers for an initial order of 6.2 tons of goods. Upon arrival at Hamburg Port, the consignment underwent full compliance random inspection by German customs, triggering five major compliance defects: excessive REACH SVHC Substances of Very High Concern, pesticide residues violating EC396 new regulations, non-compliant product labels under labelling regulations, missing raw material traceability documents, and incomplete production GMP files. The entire container was detained by customs, facing risks of return shipment, heavy fines, a 3-month delay in new product launch, and blocked European drug regulatory filing. Domestic two suppliers only provided conventional domestic national standard quality inspection certificates, lacking familiarity with complete EU compliance details and unable to conduct targeted rectification or supplementary compliance documentation. Upon recommendation by the German Natural Raw Materials Association, the client fully entrusted HiSiaddi as a Chinese compliance service provider to coordinate full-process work covering product rectification, supplementary documentation, retesting, and customs appeals to resolve the goods detention crisis and implement long-term compliant procurement.
Silymarin extract is classified as a UVCB complex natural mixture under the EU REACH Regulation. Annual import volumes exceeding 1 ton require component filing and disclosure of SVHC substances. Original manufacturers only conducted routine physical and chemical testing without screening substances on the latest updated SVHC candidate list. Trace plasticizer SVHC substances detected in finished products exceeded the 0.1% disclosure threshold, with missing REACH declarations of conformity and component traceability filing dossiers, leading German customs to directly rule the goods non-compliant and unfit for clearance.
In 2025, the EU EFSA updated the EC396 pesticide residue control standard, lowering MRL limits for chlorpyrifos and organophosphorus pesticides by 60%. Domestic manufacturers sourced scattered silymarin seeds from across regions with non-standard field pesticide application in some producing areas, resulting in exceedance of three pesticide residue items during SGS full 226-item pesticide residue screening. Original suppliers only conducted routine domestic testing of dozens of pesticide items without corresponding EU full-test reports, failing to meet German drug authority entry inspection requirements.
Domestic manufacturers retained standard domestic raw material labels bearing functional descriptions such as "liver protection, liver cell repair". The EU EFSA explicitly prohibits any therapeutic or health-care promotional claims for silymarin beyond statutory pharmacopoeia descriptions without approved dedicated liver-protection health claims. Non-compliant elements include label ingredient lists, allergen prompts, country-of-origin marking, and active ingredient presentation formats per EU 1169 Regulation, making non-compliant labels a key ground for customs detention.
The EUDR Timber and Plant Raw Material Traceability Regulation is fully enforced, requiring full traceability of plant extracts covering planting plots, harvesting, warehousing, factory entry, and production. Original suppliers purchased scattered seeds from individual farmers without planting cooperative registration, field farming logs, or origin traceability documents, unable to prove raw materials were harvested from non-deforested producing areas. Complete traceability archives were missing, preventing German importers from completing local corporate compliance declarations.
The client’s end-products require filing with Germany’s Federal Office of Consumer Protection and Food Safety (BVL), mandating supporting documents including EU-version GMP audit reports for raw material manufacturers, process validation files, and full solvent residue/heavy metal test certificates. Domestic suppliers only held domestic GMP certificates without English compliance-version production dossiers and extraction process validation records, unable to assist the client with end-product market filing in Germany.
HiSiaddi assembled a dedicated team of EU compliance specialists, plant extraction technical engineers, and third-party testing coordinators, implementing a five-step solution covering port appeals → product retesting & rectification → supplementary documentation → label revision → standardized supply chain compliance, resolving all five compliance defects within 28 days.
1. HiSiaddi partnered with an authoritative domestic testing laboratory to split all components of silymarin extract per REACH UVCB rules and screen 233 controlled substances on the latest SVHC candidate list. Excessive plasticizers were traced to precipitation from sealing pipes in the extraction workshop. Factories were coordinated to replace food-grade sealing fittings and optimize closed extraction production lines.
2. After passing retesting, English REACH dossiers and product Declarations of Conformity (DoC) were compiled, component notifications completed, and SVHC compliance disclosure documents submitted to German customs to fill gaps in importer REACH filing materials.
1. Original mixed scattered seed sources were discarded and replaced with directional seed supplies from standardized GAP planting bases in Bayannur, Inner Mongolia. Field pesticide usage logs were retrieved to strictly control harvesting and screening processes and eliminate raw materials with excessive pesticide residues from feeding.
2. Authorized EU-recognition SGS laboratories were commissioned to conduct full 226-item pesticide residue testing aligned with the latest EC396 MRL limits, issuing official English COA test reports with all pesticide residue items passing standards, and retaining batch test archives for customs verification.
1. All unauthorized promotional phrasing such as "liver protection" was deleted, with only statutory pharmacopoeia generic names and measured silymarin content marked strictly per EFSA rules. Ingredient lists, allergen prompts, country of origin, storage conditions, and manufacturer registration information were standardized.
2. Revised labels underwent pre-review by local German compliance lawyers before full-batch packaging replacement, meeting all detailed provisions of the EU food labelling regulation.
HiSiaddi coordinated with Bayannur GAP planting cooperatives to collect plot registration documents, planting logs, harvesting vouchers, raw material factory entry quality inspection records, production feeding ledgers, and finished product outbound delivery documents, building a digital full-chain traceability archive covering farmland to finished products. Complete bilingual Chinese-English documents were bound for submission to EUDR compliance declaration and passed German customs traceability review.
Cooperating manufacturers were assisted in sorting and translating EU-standard GMP audit materials, low-temperature extraction process validation reports, full solvent residue/heavy metal test certificates, and ICH Q3D elemental impurity reports. The complete English dossier was pre-submitted to Germany’s BVL Federal Food Safety Authority to meet mandatory material requirements for the client’s end-product market filing.
After completing full rectification, retesting, and document submission, the 6.2 tons of detained goods passed full re-inspection by German customs and were released for warehousing without return shipment or fines. The liver-protecting soft capsules whose launch had been scheduled for delay successfully completed German drug regulatory filing and rolled out across national German chain pharmacies.
Based on this compliance rectification implementation, Sanamed GmbH of Germany signed a long-term annual procurement framework agreement for 22.3 tons of silymarin extract with HiSiaddi. HiSiaddi established standardized compliance control workflows covering pre-audit of raw material traceability, full EU pre-testing before factory delivery, pre-review of label compliance, and accompanying REACH documentation for all shipments. All outgoing goods completed full compliance verification in advance, achieving one-time customs clearance for 12 consecutive batches over the subsequent year without any port detention incidents.
In the second year of cooperation, the client added customized procurement of organic-grade silymarin, with HiSiaddi fully managing EU organic EC834 compliance certification, organic traceability, and dedicated organic testing. Backed by this reference case of a mid-to-high-end German pharmaceutical enterprise, HiSiaddi subsequently took on silymarin raw material compliance procurement projects from three equivalent pharmaceutical enterprises in Austria and Switzerland, forming a mature full-process service system for plant extract exports to Europe and America.
Most domestic plant extract manufacturers focus on domestic national standard markets and lack sensitivity to annual updates of EU regulations including REACH, EC396, EUDR, and labelling rules. They can only meet domestic testing requirements without supporting complete compliance documentation for EU exports. Mid-to-high-end European pharmaceutical enterprises specialize in local drug regulatory systems with stringent requirements for full-chain compliance, documentary traceability, and regulatory details. Independent factory sourcing easily leads to compliance violations, goods detention at ports, and substantial economic losses.
Leveraging years of EU regulatory databases, third-party testing resources, and domestic raw material supply chain control capabilities, HiSiaddi acts as a third-party compliance service provider to connect full-process services covering pre-shipment compliance pre-review, production rectification, full-item testing, document archiving, and port clearance. It helps overseas mid-to-high-end clients mitigate cross-border trade compliance risks while supporting high-quality domestic manufacturers to improve EU-compliant production systems and smoothly enter high-end European pharmaceutical raw material supply chains.
If you wish to consult more compliance issues concerning silymarin extract products, please contact HiSiaddi customer service.
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