HiSiaddi is an innovative foreign trade service provider driven by dual engines of technology commercialization and foreign trade services. We have established a "1+2+3+4=1" service system and can supply sodium copper chlorophyllin sourced directly from multiple well-known original manufacturers. With over a decade of market experience and factory technology transformation partnerships, HiSiaddi possesses extensive expertise in product compliance issues. Below is a case handled by HiSiaddi addressing sodium copper chlorophyllin foreign trade compliance challenges.
Please contact HiSiaddi customer service for further inquiries on sodium copper chlorophyllin product compliance matters.
Purchaser: HEALTHGER Group, a premium German dietary pharmaceutical enterprise headquartered in Hamburg, Germany. It supplies raw materials for premium oral dietary capsules, medical mouthwash and cosmeceutical serums across DACH regions (Germany, Austria, Switzerland) with 26 years of industry experience. Its products are sold at high-end dm cosmeceutical counters, German national pharmacy chain APOTHEKE and premium wellness clinics in Zurich, Switzerland. Raw materials must strictly comply with EU E141 (ii) food additive specifications, EFSA safety limits, REACH regulations, Germany’s LFGB food contact legislation and EU SVHC Substances of Very High Concern control. End customers include European middle-class consumers and high-end wellness groups, with an annual sodium copper chlorophyllin procurement volume of 15.2 tons, previously sourced exclusively from Finnish imported pharmacopoeia-grade raw materials.
In 2025, the client launched its first China procurement project, signing a contract for an initial 4.2 tons of sodium copper chlorophyllin with two domestic manufacturers contacted independently. Upon arrival at Hamburg Port, goods were detained by customs and blocked from warehousing due to missing compliance documents and raw material indicators failing EU import regulatory standards, with Germany’s drug administration issuing a formal rectification notice. The detained consignment incurred heavy detention and warehousing penalties. Domestic manufacturers only held domestic food production qualifications with no familiarity with the full EU compliance system, unable to supplement overseas access documentation or adjust product indicators. The client urgently entrusted HiSiaddi with full authority to handle the full workflow covering targeted product indicator rectification, certificate supplementary application, REACH compliance improvement, customs clearance and post-mass-production compliance filing.
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Non-compliant product test indicators failing EU E141 (ii) and LFGB limit requirements Standard domestic off-the-shelf products only meet China’s GB national standards, with four indicator categories exceeding EU access limits for free copper, heavy metals (lead, arsenic, cadmium), pesticide residues and solvent residues: EU EFSA limits free copper ≤3ppm, yet tested batches upon arrival recorded 7.8~9.2ppm free copper. EU pesticide residue regulations EU 396/2005 mandate strict pesticide control, while raw materials extracted from open-air forage grass contained multiple pesticide residues exceeding EU limit thresholds. German customs laboratory testing ruled the raw materials ineligible for food additive import entry standards.
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Missing EU-mandated SDS chemical safety data sheets & non-compliant English COA reports Factories only provided Chinese factory internal inspection slips, failing to compile multilingual English SDS safety data sheets aligned with EU GHS Revision 6 regulations (complete with EC Number 234-242-5 and CAS 11006-34-1). COA test reports lacked mandatory EU-controlled test items including SVHC 224 Substances of Very High Concern screening, solvent residues and segmented heavy metal data, with German customs rejecting self-produced domestic factory inspection documents.
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Absence of CCPIT Free Sales Certificate + German Embassy Consular Authentication, blocking German drug administration filing German drug administration mandates imported food additives must be accompanied by a Free Sales Certificate (CFS) issued by China Council for the Promotion of International Trade (CCPIT) with consular authentication by the German Embassy in China, certifying legal domestic production and circulation of the product. Domestic manufacturers only provided copies of food production licenses without official commercial certification documentation, preventing the client from completing raw material filing with Germany’s drug administration and blocking retail shelf access in terminal pharmacies.
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Incomplete REACH compliance with missing SVHC notifications and tonnage pre-registration, triggering risks of EU chemical regulatory penalties With annual import volume of 15.2 tons exceeding 1 ton, REACH regulations mandate completion of substance pre-registration and SVHC Substances of Very High Concern notifications. Original manufacturers lacked an EU Only Representative (OR) and no REACH registration dossiers, leading EU customs to classify the goods as suspected illegal imports with risks of cargo return and administrative fines for the importer.
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1. HiSiaddi screened compliant mid-to-high-end manufacturers and optimized production processes: upgrade three-stage ion exchange rectification to stabilize free copper at 2.1~2.8ppm; switch extraction raw materials to organic mulberry leaves and silkworm excrement to cut pesticide residues at the source; add negative pressure solvent removal processes to eliminate methanol and acetone residues.
2. Entrust EU-recognized SGS third-party laboratories to conduct full-item testing under EU E141 (ii) specifications and Germany’s LFGB standard, issuing official bilingual Chinese-English test certificates with all heavy metal, pesticide residue and copper content indicators passing EU compliance thresholds.
3. Coordinate the factory to downgrade the original non-compliant detained consignment for domestic industrial-grade application, and expedite re-production of a 4.2-ton compliant batch under revised optimized processes.
1. Supported by chemical safety engineers, HiSiaddi compiled German-English bilingual SDS safety data sheets aligned with EU GHS and REACH substance data, fully listing CAS & EC numbers, physicochemical parameters, toxicology data, storage & transportation protection and waste disposal clauses to meet German customs declaration specifications.
2. Compile EU-format English COAs based on SGS measured test data, itemizing all E141 (ii) limit indicators, SVHC screening results and segmented heavy metal data to replace the original non-compliant Chinese factory internal inspection slips.
1. Collect full supporting documents including factory production licenses, SC food production qualifications, qualified SGS test reports and business licenses to submit applications to CCPIT, obtaining official CFS Free Sales Certificates within 3 working days.
2. Assist document submission to the German Embassy in China to complete consular endorsement authentication, delivering official certificates with embassy seals. The client used these authenticated documents to complete raw material import filing with Germany’s Federal Institute for Drugs and Medical Devices (BfArM), fulfilling all preconditions for terminal retail shelf launch.
1. HiSiaddi collaborated with EU compliance service providers to assign a German local Only Representative (OR) for sodium copper chlorophyllin, completing REACH tonnage pre-registration aligned with the client’s 15.2-ton annual procurement volume.
2. Synchronously complete full SVHC 224 Substances of Very High Concern screening and notifications, issuing REACH registration acceptance receipts and SVHC compliance statements to eliminate risks of EU chemical regulatory penalties and support long-term regular import compliance.
1. Full compliance documentation portfolio (SGS test reports, bilingual SDS, consular-authenticated CFS, REACH acceptance receipts, English COAs) shipped as original hard copies alongside the new 4.2-ton consignment to Hamburg, Germany.
2. New goods cleared customs via paperless fast-track procedures upon arrival, with German drug administration on-site document verification confirming full compliance and seamless warehousing & production without additional detention penalties.
3. HiSiaddi mediated loss compensation negotiations between the client and the original non-compliant supplier factory to fully resolve disputes over financial losses from the detained initial consignment with zero additional economic loss borne by the client.
1. HiSiaddi established an annual compliance file archive for the client: pre-audit product indicators and certificates prior to each shipment, update REACH registration information, SDS versions and annual CFS renewals yearly.
2. Lock compliant production capacity quarterly aligned with the client’s 15.2-ton annual procurement plan, delivering full EU access documentation with every shipment batch.
3. The client fully terminated procurement from Finnish suppliers and signed an annual framework purchase contract, entrusting HiSiaddi with full pre-compliance review for all new raw materials during subsequent market expansion into Austria and Switzerland.
Most domestic pigment manufacturers focus solely on domestic national standard production with limited awareness of multi-country import regulations including EU E141 (ii), REACH and Germany’s LFGB, easily resulting in non-compliant product indicators and fragmented compliance documentation. Premium European pharmaceutical enterprises face dual strict supervision from local drug administrations and customs, with any single compliance gap risking full-container detention or scrapping of goods. Supported by in-depth expertise in EU food additive and chemical regulations, HiSiaddi closed the full compliance service loop covering product rectification, third-party testing, certificate application, consular authentication, REACH registration and customs filing, resolving the client’s port detention crisis via simultaneous rectification of both product quality and supporting documentation, and securing stable long-term repeat orders via professional compliance capabilities.
Please contact HiSiaddi customer service for further inquiries on sodium copper chlorophyllin product compliance matters.
+86-13120989737 
info@hisiaddi.com 
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