HiSiaddi is an innovative foreign trade service provider driven by dual pillars of technology commercialization and foreign trade services, with a "1+2+3+4=1" service system and supply access to green tea extract (EGCG 90%) from multiple well-known original manufacturers. With over a decade of market experience and technological cooperation with manufacturers, HiSiaddi boasts rich experience addressing product compliance issues. Below is a case study on resolving compliance problems of green tea extract (EGCG 90%).
For inquiries about more compliance issues of green tea extract (EGCG 90%), please contact HiSiaddi customer service.
Client: NutriSante from France, a top-tier natural health brand in France specializing in premium antioxidant capsules and organic herbal oral liquids. Its products are sold at high-end pharmacies, private clinics and organic supermarkets across Western Europe including France, Switzerland and Belgium, fully complying with EU EFSA, Regulation (EU) 2022/2340, cGMP and French food safety standards. At the end of 2025, the client upgraded its core antioxidant product line and planned to purchase green tea extract with EGCG ≥90%, yet encountered multiple compliance barriers blocking customs clearance and market launch. The client urgently entrusted HiSiaddi to deliver a full-chain compliance solution.
Regulation (EU) 2022/2340 mandates strict rules: daily EGCG intake ≤800mg; labels must mark the exact EGCG content per serving, plus four mandatory warning statements: "Not for pregnant/lactating women or individuals under 18", "Do not take on an empty stomach" and "Caution for people with liver dysfunction". The client’s original supplier only provided basic COA without compliant label templates or warning statement texts, making products unmarketable.
France enforces strict internal control standards for raw material heavy metals (lead ≤0.5ppm, arsenic ≤0.05ppm) and solvent residues (≤20ppm). Samples from 3 manufacturers sent by the client for testing all failed inspection, with lead content ranging 0.8–1.2ppm and solvent residues 35–50ppm, unable to pass French customs and market supervision sampling inspections.
High-end markets require EU organic certification, ISO22000, HALAL certificates, non-GMO statements and complete traceability reports covering the full chain from tea garden base to extraction, purification and packaging. Cooperative manufacturers only supplied basic quality inspection reports, lacking key international certifications and fragmented traceability information, failing client supplier audits and EU filing requirements.
Some manufacturers labeled "tea polyphenols ≥90%" while actual EGCG content only ranged 75–85%, without separate clear marking of EGCG content. They could not provide precise test reports for EGCG monomers, violating the mandatory requirement of "explicit EGCG content labeling" stipulated in the new regulation.
EGCG content fluctuated ±5% across batches, and caffeine content varied 0.5–1.5%, making it difficult to stably control daily intake of end products and creating hidden risks of excessive intake violations, failing the procurement standard of "consistent batches and controllable risks" for premium brands.
Regulation (EU) 2022/2340 was interpreted in depth combined with local French requirements to customize bilingual (French/English) compliant label templates with clear marking of:
· Exact EGCG content per serving (e.g., "450mg EGCG per capsule");
· Four mandatory warning statements (French + English);
· Production batch number, expiry date and traceability QR code. A compliant text library covering product specifications, brochures and e-commerce page descriptions was provided to avoid promotional violations. EU regulatory filing was completed simultaneously to enable free circulation of products across all 27 EU member states.
Two manufacturers with EU-compliant production qualifications (Shanghe Biotech, Zhejiang Damingtang) were selected and required to rectify processes:
· Raw material end: Organic green tea bases with low heavy metal levels were chosen, with soil and tea leaf heavy metal testing conducted before harvesting to control pollution from the source;
· Extraction end: Supercritical CO₂ extraction and low-temperature chromatography replaced traditional organic solvents to limit solvent residues ≤15ppm;
· Purification end: Additional ion exchange resin and activated carbon deep adsorption procedures were added to reduce lead ≤0.3ppm, arsenic ≤0.03ppm and cadmium ≤0.02ppm, far below EU limits. EU-recognized third-party test reports (ICP-MS testing) with detailed test methods and data were provided for each batch to ensure traceability and recheckability.
Assisted manufacturers in expediting EU organic certification, ISO22000, HALAL and non-GMO certification acquisition, alongside FDA registration and EU food enterprise filing documents. A full-link traceability system was built: tea garden base (planting records, pesticide usage records) → extraction workshop (production parameters, process records) → purification workshop (test data, batch records) → packaging (material testing, sealing records) → outbound delivery (logistics information, quality inspection reports). A unique traceability QR code was generated, enabling full-process information review via scanning to satisfy EU traceability requirements.
Manufacturers were required to conduct precise independent testing of EGCG monomers to guarantee EGCG ≥90% (actual measured value ≥90.5%), with separate special test reports for EGCG content. Vague labeling replacing EGCG with tea polyphenols was prohibited. Unified labeling standards were implemented to ensure consistent EGCG content across COA, labels and test reports, clearly distinguishing "tea polyphenols" and "EGCG monomers" in compliance with new regulation labeling rules.
Exclusive high-end quality control standards were formulated: EGCG content fluctuation ≤±1%, caffeine ≤0.3%, moisture ≤2.8%, stable powder flowability. Complete quality control reports covering raw material testing, in-process testing and finished product testing (including deviation analysis and rectification records) were provided for each batch to guarantee batch consistency. A batch traceability and recall mechanism was established to quickly locate problematic batches and conduct recalls if compliance risks emerge, reducing brand losses.
HiSiaddi coordinated manufacturers to produce compliant samples, which were tested by a third-party laboratory in France with the following results:
· Heavy metals: Lead 0.28ppm, arsenic 0.02ppm (meeting standards);
· Solvent residues: 12ppm (meeting standards);
· EGCG content: 90.8% (meeting standards);
· Labels and texts: Fully compliant with Regulation (EU) 2022/2340.
The full set of certification documents, traceability reports and compliant label templates passed client review and EU filing without omissions or defects.
The first batch of 500kg compliant raw materials smoothly passed French customs sampling inspection with zero violations and zero cargo detention. After end product launch, they passed random inspections by French market supervision authorities with full compliance and zero compliance complaints.
Four major compliance problems including label irregularities, excessive residues, incomplete certifications and non-standard labeling were completely resolved. Products fully met EU and French high-end market standards and were successfully launched with strong sales performance.
Subsequent bulk raw materials delivered consistent quality across batches, with stable EGCG ≥90.5% and caffeine ≤0.3%, free of any quality fluctuation issues.
The client highly recognized HiSiaddi’s professional compliance capabilities, resource integration strengths and end-to-end implementation capacity, designating HiSiaddi as its exclusive supplier for compliant EGCG raw materials from China with stable annual procurement volume of 2–3 tons. The client later entrusted HiSiaddi with expanding procurement of high-end raw materials including curcumin extract and milk thistle extract, continuously broadening cooperative product categories.
This compliance solution has become a benchmark for EGCG raw material compliance in France’s high-end dietary supplement market and is referenced by numerous peer brands.
For overseas mid-to-high-end clients purchasing EGCG 90% green tea extract, compliance is the lifeline and core barrier for premium brands. Following the entry into force of Regulation (EU) 2022/2340, low-grade raw materials and extensive production modes can no longer adapt to high-end market demands.
HiSiaddi’s core value lies in its "profound regulatory expertise + resource integration + closed-loop implementation": it possesses in-depth mastery of EU and French compliance rules, resource capacity to screen and rectify qualified manufacturers, and end-to-end delivery capabilities covering label customization, process rectification, certification handling and traceability construction. It helps clients completely eliminate compliance risks and realize stable supply of premium products.
For inquiries about more compliance issues of green tea extract (EGCG 90%), please contact HiSiaddi customer service.
+86-13120989737 
info@hisiaddi.com 
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