As a new type of foreign trade service provider driven by technological transformation and export business, HiSiaddi has built a "1+2+3+4=1" service system and can supply graviola extract sourced from multiple well-known original manufacturers. With over a decade of market experience and technological collaboration with manufacturers, HiSiaddi possesses extensive expertise in product compliance issues. Below is a case study of HiSiaddi’s resolution of compliance challenges for graviola extract products.
If you wish to consult further compliance issues regarding graviola extract products, please contact HiSiaddi customer service.
The purchaser is BIOREVE SAS, based in Paris, France, a leading domestic mid-to-high-end brand for dietary supplements and clinic skincare products. Its goods are sold in premium French organic pharmacies, private wellness clinics and duty-free beauty stores across multiple EU member states, with two core product categories: graviola dietary soft capsules and anti-aging essence raw materials. Raw materials must comply with full EU compliance standards including EC 396 226-pesticide-residue regulations, LFGB, REACH, CPNP cosmetic notification, EU Novel Food regulations and EU-GMP. Annual graviola extract procurement volume: 12.5 tons. The client previously sourced raw materials from two domestic plant extract manufacturers. Four critical compliance hard defects emerged shortly before vessel loading, preventing normal export customs clearance and carrying high risks of detention or destruction upon arrival at EU borders with daily costly warehousing penalties. The client urgently entrusted HiSiaddi with full coordination of compliance rectification.
The two supplying manufacturers only conducted basic domestic standard testing without screening for 226 pesticide residues per EU Regulation (EC) No 396/2005. Sampling testing detected trace excess organophosphorus pesticides and benzopyrene, with lead and cadmium heavy metal concentrations exceeding EU Pollutant Limits Regulation 2023/915. Factories could only provide internal self-inspection reports rather than full English COA certificates issued by EU-recognized laboratories (SGS/PhytoLab), guaranteeing customs detention of full containers upon arrival at EU entry ports.
Client product labeling specifies whole Ecuadorian fruits as feedstock, yet domestic manufacturers cannot provide complete Ecuadorian farm GAP cultivation archives, fruit origin certificates and import customs declaration documents. New EU regulations mandate full traceability of plant-derived extracts back to planting farms; incomplete traceability documents result in official classification as unknown origin, violating EFSA food safety traceability control requirements.
Half of the extract is used for dietary soft capsules and half for compounding clinic essence serums:
· Dietary applications lack EU REACH substance pre-registration;
· Skincare applications have no official raw material filing on the EU CPNP cosmetic notification platform. EU regulations prohibit domestic blending, production and sales within EU territory for cosmetic raw materials without CPNP notification or chemical raw materials without REACH registration numbers.
English labels on original outer packaging omit mandatory information including active ingredient content, plant Latin binomial, manufacturer details and storage conditions, with labeled data inconsistent with test reports. Inner plastic bag materials lack LFGB food contact material testing certification. EU customs classify labeling as false and identify safety hazards from raw material contact packaging, denying entry clearance.
Manufacturer pain point: Most domestic plant extract factories specialize in production and processing but lack expertise in segmented multi-country EU regulations. They can only rectify product active ingredient content without dedicated compliance specialists to coordinate overseas regulatory requirements, third-party certification and registration filing, and are unwilling to bear costs to complete full-set compliance documentation.
HiSiaddi assembled a dedicated task force of overseas regulatory specialists, CNAS testing coordinators, traceability customs specialists and label auditors to resolve all compliance issues within a 45-day closed-loop timeline with phased rectification implementation:
1. Coordinate manufacturers to screen qualified raw material batches and segregate pesticide-residue-excess inventory; remaining compliant raw materials are blended with feedstock from exclusive Ecuadorian GAP farms;
2. Engage domestic SGS laboratories holding EU qualification to complete full testing covering 226 pesticide residues, heavy metals and microorganisms per EC 396 and EU 2023/915 standards, issuing authoritative bilingual Chinese-English COA test reports. Excess inventory is diverted separately to low-grade domestic feed applications with no export to the EU.
HiSiaddi coordinates partner organic farms in Ecuador to supplement fruit origin certificates, field plant protection records, soil testing reports and ocean import customs declaration documents, establishing a full traceability ledger covering South American plantations to domestic processing factories. All documents are notarized in English and filed to satisfy EU border traceability verification requirements per EUR-Lex regulations.
1. For dietary-grade extracts: HiSiaddi leverages compliance resources to complete EU REACH pre-registration, obtaining exclusive registration numbers and English SDS safety data sheets complying with EU chemical circulation regulations;
2. For skincare-grade raw materials: Complete official raw material filing on the EU CPNP cosmetic notification system per EU Cosmetics Regulation 1223, inputting raw material INCI names and CPSR safety assessment reports to obtain official filing receipt numbers.
1. Customize new full-English outer packaging labels fully aligned with EU specifications, clearly marking Latin plant binomial, measured annonaceous acetogenin content, manufacturer, country of origin, storage conditions and shelf life, with all data consistent with COA test reports;
2. Replace packaging with LFGB-certified 316L stainless steel inner liners and food-grade kraft paper drums, providing LFGB test certificates for packaging materials to eliminate food contact material compliance risks.
After full compliance documentation and product rectification, re-testing of all indicators by the client’s French third-party laboratory achieved full compliance. Goods previously at risk of detention completed domestic customs clearance and ocean shipment without incident, passing one-time customs inspection upon arrival at Le Havre Port, France with no detention or fines incurred. The client smoothly deployed raw materials to its own GMP production workshop: dietary soft capsules launched across premium French chain pharmacies, and anti-aging essence serums entered offline high-end medical beauty institutions in Paris. A full-year framework procurement order for 12.5 tons split into multiple shipments was finalized. Subsequent new demand for organic-certified graviola extract procurement entrusts HiSiaddi with upfront compliance pre-audit to avoid future regulatory risks.
EU mid-to-high-end market access regulations feature detailed segmentation with vastly different compliance requirements for dietary and cosmetic dual-use raw materials. Most domestic plant extract manufacturers lack overseas regulatory reserves and compliance filing capabilities. Leveraging cross-border compliance resources, HiSiaddi implements upfront risk control covering pesticide residues, traceability, registration filing and labeling to avoid losses including goods return and confiscation, breaking compliance barriers preventing domestically produced plant extracts from entering high-end EU supply chains.
If you wish to consult further compliance issues regarding graviola extract products, please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
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