As a new-type foreign trade service provider driven by both technology transformation and foreign trade services, HiSiaddi has established a "1+2+3+4=1" service system and can supply raw materials of Pueraria Mirifica extract from multiple well-known original manufacturers. Possessing over a decade of market experience as a technology R&D-oriented foreign trade enterprise and long-term technological transformation cooperation with manufacturers, HiSiaddi boasts rich experience addressing product compliance issues. Below is a case of HiSiaddi resolving compliance challenges for Pueraria Mirifica extract exports.
If you wish to consult more compliance issues related to Pueraria Mirifica extract products, please contact HiSiaddi customer service.
The purchaser is NaturaPrime B.V. based in Amsterdam, the Netherlands, a leading mid-to-high-end dietary brand in the Netherlands with core products of Pueraria conditioning soft capsules and organic oral liquids sold across premium Dutch organic supermarkets, private wellness clinics and high-end Belgian pharmacies. Raw materials must comply with EUDR timber traceability regulations, REACH registration, EC396 covering 226 pesticide residue items, LFGB food raw material standards, EU food labeling regulation EU1169/2011 and BVL Dutch import filing requirements, with an annual Pueraria Mirifica extract procurement volume of 11.2 tons (pharmaceutical-grade with total isoflavones ≥40%, puerarin ≥22%).
The client previously sourced raw materials from European and American agents, yet launched direct China sourcing in 2025, selecting two domestic leading plant extract manufacturers for stock preparation. Five major compliance bottlenecks emerged shortly before shipment, exposing the entire cargo to risks of customs detention and return in the EU, with potential losses exceeding 32,000 Euros for full-container return. Manufacturers could only provide basic quality inspection reports with no supporting capabilities for EU compliance, prompting the client to entrust HiSiaddi with full authority to remediate all compliance items.
Pueraria is a terrestrial agricultural and forest crop. EUDR mandates full-chain traceability filing covering farmers, harvesting, crude processing and extraction factories, including plot numbers, pesticide application records, origin certificates and harvesting compliance declarations. Original manufacturers could only provide finished COA with no Enshi Hubei GAP field ledgers or farmer filing documents, lacking English traceability dossiers. Dutch customs enforce zero tolerance for cargo without EUDR documentation under the new regulation, triggering immediate detention and inspection.
The client’s annual procurement volume of 11.2 tons exceeds 1 ton, triggering REACH registration obligations. Original manufacturers only completed preliminary substance declarations without supplementary GLP laboratory physicochemical and toxicology dossiers or SVHC Substances of Very High Concern test reports, preventing the Dutch importer from completing annual import reporting in the EU ECHA system.
Testing by domestic third-party laboratories commissioned by manufacturers produced incomplete SGS reports: cadmium reached 0.38 mg/kg (EU upper limit: 0.3 mg/kg), and test data for multiple niche pesticides were missing, failing to comply with the EC396 uniform limit standard of 0.01 mg/kg. Reports were issued in Chinese with simple English translations, unrecognized by Dutch drug regulatory authorities for product shelf filing.
Manufacturers retained domestic labels carrying efficacy claims such as "improves endocrine function, nourishes ovaries". The EU EFSA only approves a narrow whitelist of physiological function descriptions; medical-style claims will be classified as pharmaceutical products requiring stringent herbal medicine registration procedures. Labels lacked allergen warnings, Latin botanical name (Pueraria lobata), country of origin and standardized net content markings, risking cargo removal and recall upon port arrival.
Dutch regulations mandate importers complete raw material filing with the federal food safety authority BVL prior to dietary supplement raw material import. Original manufacturers provided no supporting English filing documents or process specification files, preventing the client from completing official Dutch system declarations and customs clearance & warehousing.
HiSiaddi set up a task force of foreign trade compliance specialists, plant extract technical staff and EU certification consultants, coordinating manufacturers, domestic authoritative GLP laboratories and EU compliance agencies to close all compliance procedures within 22 days:
HiSiaddi conducted on-site coordination with contracted GAP planting cooperatives in the Pueraria origin of Enshi, Hubei, compiling three-year Chai Ge plot ledgers, farmer harvesting registration forms, field pesticide application records and original origin certificates. Full English traceability dossiers were prepared per EU standard EUDR templates and uploaded to the EU Timber Regulation declaration system to obtain official acceptance receipts, supplementing full-chain traceability credentials.
HiSiaddi coordinated manufacturers to supplement SVHC 197 high-concern substance testing, commissioned EU GLP-qualified laboratories to conduct simplified supplementary physicochemical and toxicology tests, updated REACH pre-registration technical dossiers, and assisted the Dutch client in completing annual import tonnage reporting of 11.2 tons in the ECHA system to obtain ECHA system declaration receipts.
HiSiaddi selected SGS laboratories recognized by the EU to conduct retesting of 226 pesticide residue items, four heavy metals, aflatoxins and PAH polycyclic aromatic hydrocarbons per EC396 regulations. Small batches of raw materials failing indicators were isolated and discarded; qualified batches were retested to reduce cadmium levels to 0.22 mg/kg with all pesticide residues falling below EU MRL limits. Full English COA reports carrying laboratory qualification serial numbers were issued, directly applicable to Dutch drug regulatory filing.
New Chinese-English outer carton labels were redesigned per EU1169 regulations, deleting all medical efficacy descriptions and only retaining compliant physiological function statements. Supplementary markings included Pueraria Latin botanical name, country of origin (China), raw material ingredients, storage conditions and allergen prompts. All labels passed pre-review by Dutch compliance lawyers, meeting shelf labeling requirements for supermarkets.
HiSiaddi compiled full English raw material process specifications, botanical origin certification and a summary volume of compliance test documents, assisting the Dutch import enterprise in completing dietary raw material import declarations on the BVL official website and obtaining filing receipts from the Dutch Food Safety Authority to meet pre-shipment mandatory customs clearance conditions.
After remediation, the first batch of 3.8 tons of Pueraria Mirifica extract was shipped from Shanghai to Rotterdam Port. Dutch customs inspected the full set of compliance documents, test reports, EUDR dossiers and BVL filing receipts, clearing the goods for release in one inspection. Raw materials entered warehouse and were put into soft capsule mass production, with finished products successfully launched across all premium Dutch supermarkets. The client canceled cooperation with the original two scattered manufacturers and signed an annual fixed procurement framework of 11.2 tons with HiSiaddi, entrusting HiSiaddi to coordinate compliance control and select matching compliant raw materials from leading domestic manufacturers. The client later added customized procurement of organic-grade Pueraria Mirifica extract, with HiSiaddi locking organic-certified bases in advance and completing organic certification, pesticide residue screening and import filing upfront to achieve zero customs detention across all shipments throughout the year.
Most domestic plant extract manufacturers excel in production and processing yet lack familiarity with annually updated EU regulations including EUDR, REACH and national import filing rules across European countries, only meeting domestic national standard requirements. Mid-to-high-end European clients specialize in terminal regulatory compliance yet lack insight into China’s raw material traceability systems and domestic certification rules, making independent procurement prone to compliance traps. Leveraging cross-border compliance databases and domestic & international certification resources, HiSiaddi bridges full-chain compliance gaps from raw material origin to export customs clearance, avoiding massive return losses and opening a stable compliance channel for domestic Pueraria Mirifica extract to enter the high-end Dutch dietary supply chain.
If you wish to consult more compliance issues related to Pueraria Mirifica extract products, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
English
