As a new-type foreign trade service provider driven by both technology transformation and foreign trade services, HiSiaddi has built a "1+2+3+4=1" service system and can supply raw materials of Echinacea Purpurea Extract from multiple well-known original manufacturers.
With over ten years of market experience and technological cooperation with factories, HiSiaddi possesses rich expertise in product compliance issues. Below is a case of HiSiaddi resolving compliance problems for Echinacea Purpurea Extract foreign trade.
Please contact HiSiaddi customer service if you require more consultation on Echinacea Purpurea Extract product compliance issues.
The buyer is BioSan GmbH based in Bavaria, Germany, a mid-to-high-end domestic dietary supplement brand with products sold in premium organic lines of German DM supermarkets, national German chain pharmacies and Austrian health chain institutions. Its core products include premium Echinacea soft capsules and adult herbal oral liquids. Raw materials must meet full sets of access standards: EUDR timber traceability regulation, REACH, EC396 standard covering 226 pesticide residue items, EU organic certification, HMPC European Herbal Pharmacopoeia and TRACES import declaration requirements. The annual planned procurement volume of pharmaceutical-grade Echinacea Purpurea Extract (cichoric acid ≥4.0%) totals 9.8 tons.
The client independently sourced raw materials from two domestic plant extract manufacturers for the first time, paying deposits and reserving shipping space. Right before shipment, four major compliance hard defects emerged, leading to rejection of raw material filing during local German drug regulatory pre-review, with EU customs predicting detention upon arrival at the port. Goods could not be shipped out. Manufacturers could only provide conventional factory COA reports, lacked familiarity with EU import regulations and were unable to supplement overseas access documents. The client faced triple losses including deposit forfeiture, delayed new product launch and empty container liquidated damages, and urgently entrusted HiSiaddi to fully coordinate compliance rectification.
EUDR regulation requires full-chain traceability of herbal Echinacea raw materials covering overseas farm harvesting, processing and export, with mandatory supporting documents including planting plot numbers, harvesting vouchers, farmer archives and TC transaction certificates for origin traceability. Original suppliers sourced raw materials scattered from farmers in Hebei and Shanxi without targeted GAP planting bases, making it impossible to issue full-chain traceability documents. Key traceability codes were missing for entry into the EU TRACES traceability system, prohibiting customs clearance of the entire batch of goods.
Manufacturers only conducted routine domestic testing covering a dozen pesticide residue items, without completing full 226-item screening in compliance with EC396 standards. Three pesticide residues approached EU limit thresholds, and cadmium heavy metal indicator exceeded the standard by 0.02ppm. Issued COA reports were conventional domestic laboratory certificates, not issued by EU-accredited institutions such as SGS or Rheinland, which were not accepted by German drug regulatory authorities and could not be used for product filing.
Echinacea Purpurea Extract is classified as a UVCB complex plant extract. Manufacturers failed to complete REACH pre-registration corresponding to the procurement tonnage. Trace solvent residues contained in products fell under the SVHC control list, without submission of SVHC substance disclosure documents to downstream clients. Per German regulations, raw materials without REACH registration are prohibited from entry and production.
The client’s order included 3.2 tons of EU organic-grade Echinacea powder. Manufacturers only held domestic organic certificates, lacking Ecocert-issued EU equivalent organic certifications and single-batch COI customs clearance certificates mandatory for EU entry. EU organic supervision rules clearly stipulate that organic products without COI certificates will be directly returned and the entire container confiscated.
HiSiaddi set up a team consisting of plant extract compliance specialists, third-party testing coordinators and EU regulation specialists, implementing closed-loop resolution in four phases: raw material replacement & traceability supplementation → third-party re-testing & rectification → qualification supplementation → standardized documentation preparation.
HiSiaddi coordinated a switch to standardized GAP-certified Echinacea Purpurea planting bases under signed contracts in Chifeng, Inner Mongolia, locking fixed plots for harvesting. Cooperated with bases to organize cadastral plot documents, harvesting ledgers, farmer filing forms and raw material outbound invoices, coordinating EU-accredited certification bodies to issue batch-specific EUDR traceability TC certificates. Complete data was entered into the EU TRACES traceability system to obtain official traceability filing codes.
EU-accredited SGS laboratories were selected for full-item re-testing complying with EC396 (226 pesticide residues) and EU2021/1317 heavy metal standards. Non-compliant batches of raw materials were eliminated and replaced with qualified feedstock. Post-re-testing, all pesticide residue and heavy metal indicators fell within EU limits, with authoritative bilingual COA test reports issued acceptable to German drug regulatory authorities, clearly labeling measured cichoric acid values and the plant Latin name Echinacea purpurea (complying with HMPC Pharmacopoeia labeling specifications).
Leveraging industry resources to act as agent for REACH pre-registration of Echinacea Purpurea Extract corresponding to the procurement tonnage to obtain REACH registration numbers. Conducted SVHC screening on finished products, sorting out a list of substances exceeding the 0.1% control limit and issuing English SVHC disclosure statements to meet German downstream manufacturers’ regulatory filing requirements.
For organic-grade raw materials, Ecocert conducted on-site audits of factory production environments and full-process workflows to issue EU equivalent organic certificates. Batch-specific mandatory COI customs clearance certificates for EU import were processed separately for each shipment, ensuring full consistency of information across organic certification documents, customs declaration materials and bills of lading to avoid customs clearance risks arising from inconsistent documents.
Additional English supporting documents were organized including production qualification certificates, GMP workshop audit reports, full microbial test reports (per USP61/62 standards) and allergen declaration files, packaged into filing dossiers complying with German drug regulatory requirements, assisting the client in completing pre-review filing of raw materials in Germany.
After full review and approval of all compliance documents, the full 9.8-ton batch of goods was successfully shipped from Shanghai Port, passing one-time customs inspection upon arrival at Hamburg Port without detention or random inspection seizure. Raw materials entered production and smoothly completed domestic German product filing, with premium soft capsules and organic oral liquids launched on schedule across all pharmacy channels. The client subsequently signed an annual compliance supporting cooperation agreement with HiSiaddi, with raw materials purchased in 10 monthly batches throughout the year. HiSiaddi conducted pre-review of full compliance documents for all shipments, achieving zero customs clearance failures and zero RASFF notifications for 12 consecutive months. Backed by this compliance service record, the client referred two equivalent mid-to-high-end dietary enterprises from the Netherlands and Austria for raw material procurement cooperation the following year.
Most domestic plant extract manufacturers focus on production and lack awareness of new EU import regulations (EUDR, REACH, organic COI), only capable of meeting conventional domestic standards. Mid-to-high-end overseas pharmaceutical enterprises possess in-depth knowledge of local drug regulatory rules yet lack familiarity with China’s raw material traceability, testing and certification systems. Independent procurement easily triggers compliance barriers. Relying on cross-border regulatory resources covering China and Europe, HiSiaddi fills compliance gaps across the full industrial chain from raw material sources to customs clearance documents, breaking down compliance barriers preventing high-end domestic plant extracts from entering premium EU markets.
Please contact HiSiaddi customer service if you require more consultation on Echinacea Purpurea Extract product compliance issues.
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info@hisiaddi.com 
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