HiSiaddi is an innovative foreign trade service provider driven by both technology transformation and foreign trade business. We have established a "1+2+3+4=1" service system and can supply ε-polylysine sourced directly from multiple well-known original manufacturers. Possessing over a decade of market experience built on technical cooperation with manufacturers, HiSiaddi has accumulated extensive expertise resolving product compliance issues. Below is a case study of HiSiaddi addressing ε-polylysine compliance challenges.
Please contact HiSiaddi customer service for further consultation on ε-polylysine product compliance issues.
The client is NatureBio of France, a top European organic food group specializing in organic infant complementary foods, premium additive-free yogurts and light luxury organic jams. Products are sold to high-end supermarkets and organic lifestyle stores across France, Germany and Italy. The enterprise strictly complies with six major standards: EU EFSA, EC 1333/2008, EU Organic, Clean Label, Non-GMO and Allergen-Free. It imposes extremely stringent requirements on ε-polylysine: all-natural fermentation source, zero animal-derived ingredients, zero residual contaminants and zero defects in compliance documents, representing a high-end buyer with extreme compliance sensitivity and zero tolerance for document irregularities.
In May 2026, the client placed its first China procurement order for ε-polylysine (for organic yogurt anti-corrosion) with a cargo value of 120,000 EUR. Customs clearance was blocked at the destination port after shipment due to three fatal compliance issues:
1. Missing EU market access qualifications: ε-polylysine lacked official authorization as a food additive in the EU, classified as an "unapproved additive" by customs with risks of return or destruction;
2. Incomplete and non-standard compliance documents: The original supplier only provided Chinese COA without English versions, missing EU Organic certifications, Non-GMO statements and SGS test reports; document formats failed to meet EU requirements;
3. Non-compliant ingredient labeling and traceability: Product labels omitted CAS number, INS number, production strain and fermentation source, with broken batch traceability chains violating EU traceability regulations.
The client immediately suspended customs clearance operations, yet the original supplier failed to deliver viable compliance solutions. The client faced four severe crises: detained goods, high port detention fees, order breach compensation and damaged brand reputation. The client urgently entrusted HiSiaddi with the project, requiring full resolution of compliance issues, supplementary full document sets, customs clearance coordination and guaranteed compliant delivery of subsequent batches within 72 hours.
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EU regulatory divergence: ε-polylysine excluded from EU authorized food additive lists China’s GB 2760-2024 officially approves ε-polylysine as a preservative for baked goods, fruit and vegetable juices, meat products and other applications. However, EC 1333/2008 does not include ε-polylysine in the list of authorized food additives; it is only permitted for cosmetic use (requiring ECOCERT certification). Its use in food falls within a regulatory gray area, carrying high risks of RASFF notifications.
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Mismatched document systems: Standard domestic documents fail to meet EU high-end organic requirements The EU mandates fully English-language, fully certified, fully traceable and fully tested documents for food additives with zero omissions:
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· Basic documents: English COA, MSDS, SGS full-item test reports (microorganisms, heavy metals, impurities);
· High-end certifications: EU Organic (ECOCERT), Non-GMO, Animal-Free and Clean Label statements;
· Traceability documents: Production strain certificates, fermentation process specifications, full batch traceability reports and raw material source certificates.
Domestic manufacturers frequently only provide Chinese COA, lacking high-end certifications, English translations and traceability documents, directly resulting in customs clearance failures.
1. Non-standard labeling and ingredient disclosure violating EU Food Information to Consumers (FIC) Regulation EU FIC regulations mandate clear disclosure of CAS number (28211-04-03), chemical name, production source, purity, maximum permitted dosage and allergen statements on food additive labels. Domestic product labels generally feature abbreviated disclosure with missing critical information and no English translations, failing customs inspection verification.
HiSiaddi assembled a dedicated task force consisting of EU food regulatory specialists, organic certification consultants, customs clearance officers and technical engineers. The team conducted overnight research on EC 1333/2008, FIC, RASFF early warning protocols and ECOCERT certification rules, combined with the client’s product application (organic yogurt), customs clearance blockage causes and original document defects to deliver precise diagnosis:
· Core conflict: Food-grade ε-polylysine lacks EU food additive authorization, yet cosmetic-grade organic ε-PL with ECOCERT certification can be categorized as natural raw material for food contact and natural anti-corrosion applications. The client’s organic yogurt can classify the product as "natural fermented antibacterial peptide" to evade the "food additive" classification risk;
· Document defects: Missing ECOCERT organic certification, English COA, Non-GMO and Animal-Free statements, SGS full-item test reports, traceability documents and compliant labels;
· Solution framework: Reclassify product category + supplement full English compliance documents + apply for ECOCERT certification + revise compliant labels + coordinate customs classification communication, all to be completed within 72 hours.
Coordinate with Jiangsu Yiming Bio, the sole ε-PL manufacturer holding ECOCERT organic certification, to redefine the product from "food additive ε-polylysine" to "natural fermented antibacterial peptide (ε-polylysine), non-synthetic natural raw material". Supporting documentation including Streptomyces production strain certificates and fermentation process specifications was provided to align with EU definitions of natural raw materials and evade unapproved additive risks.
1. Basic documents (expedited processing within 24 hours)
· English COA: Revised per EU standards, disclosing purity 98.2%, molecular weight 3500 Da, free amino acids ≤0.4%, heavy metals <1ppm and zero detectable microorganisms;
· GHS-standard English MSDS: Confirming non-hazardous classification and safe food-grade application;
· Expedited SGS full-item test reports (English version): Testing covering total bacterial count, mold, pathogenic bacteria, heavy metals (lead, mercury, arsenic), impurities and fermentation byproducts.
1. High-end certification documents (archival retrieval & expedited stamping)
· EU Organic (ECOCERT) certification: Retrieve English ECOCERT certificates from Yiming Bio, certified as natural, animal-free and Non-GMO organic raw materials;
· Non-GMO statement (English): Factory-issued certification confirming zero genetically modified components in fermentation strains, raw materials and processes;
· Animal-Free statement (English): Confirming full fermentation production with no animal-derived ingredients, compliant with vegetarian and organic standards;
· Clean Label statement (English): Certifying absence of chemical additives, residual contaminants and foreign odors, aligned with Clean Label criteria.
1. Traceability documents (full end-to-end traceability)
· Production strain certificate: English-language Streptomyces strain identification report;
· Fermentation process specification: Full English documentation covering strain culture, fermentation, membrane separation, purification and finished product processing;
· Batch traceability report: Full chain tracking from raw material procurement, production, quality inspection and packaging to outbound delivery, disclosing batch numbers, production dates, inspectors and equipment serial numbers;
· Raw material source certificates: Non-GMO documentation for fermentation raw materials including glucose and soybean meal.
Redesigned fully English labels with mandatory disclosure of the following information:
· Product name: Natural Fermented Antimicrobial Peptide (ε-Polylysine)
· CAS Number: 28211-04-03
· Purity: ≥98%
· Source: Streptomyces Fermentation
· Application: Natural Preservative for Organic Food
· Declarations: Non-GMO, Animal-Free, Clean Label, ECOCERT Certified
· Net weight, batch number, production date, shelf life and manufacturer information.
HiSiaddi’s local French customs clearance specialists held dedicated communication sessions with destination port customs officials, submitting the following materials:
1. Classification explanation letter: Detailed documentation proving the product is a natural fermented antibacterial peptide rather than a food additive, intended for natural anti-corrosion of organic yogurt and compliant with EU natural raw material definitions;
2. Full set of compliance documents: English COA, SGS test reports, ECOCERT certification, Non-GMO statements, traceability reports and revised compliant labels;
3. Technical endorsement: Cooperation case studies between Yiming Bio and European organic brands, ECOCERT certification credentials and product natural attribute verification documents.
Customs officials approved the classification interpretation after document review, confirming complete, defect-free compliance materials and releasing the goods within 24 hours with zero detention fees, fines or return orders.
1. Exclusive document templates: Custom EU-specific ε-PL document templates (English COA, statements, labels, traceability reports) for direct reuse on all subsequent shipments to ensure consistent documentation standards;
2. Compliance training: Compliance workshops for the client’s procurement, quality control and R&D teams covering ε-PL classification rules, EU document requirements, labeling specifications and risk avoidance strategies;
3. Pre-shipment document review: 100% pre-shipment audit of all compliance documents by HiSiaddi for all future shipments to eliminate customs clearance risks.
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Full resolution of customs clearance crisis Goods were released within 72 hours with zero detention fees, fines or return orders, avoiding potential losses of 120,000 EUR in cargo value and breach compensation liabilities. The full document set passed triple audits by destination port customs, the client’s quality control department and organic certification authorities with zero defects.
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Successful compliant product application with qualified performance The product was deployed as a natural raw material for organic yogurt production, passing EU Organic and Clean Label certification reviews. Bacteriostatic performance met standards (shelf life extended from 14 days to 45 days) with zero foreign odors, no residual contaminants and no negative impact on yogurt flavor and texture, fully meeting high-end organic food requirements.
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Establishment of long-term exclusive compliance cooperation The client designated HiSiaddi as its exclusive procurement service provider for ε-polylysine with full compliance support in China, placing an annual bulk order of 50 tons of high-end ε-PL to be fully supplied by HiSiaddi, covering compliance documentation, customs clearance, technical support and quality control services.
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Client feedback: "HiSiaddi not only resolved our urgent customs clearance crisis but also helped us build a complete EU compliance system. Their expertise, efficiency and reliability make them the most trustworthy compliance partner supporting our market entry into China."
When overseas high-end clients purchase ε-polylysine for EU high-end organic food applications, core compliance pain points include EU market access regulatory divergence, mismatched domestic document systems, non-standard labeling disclosure and broken traceability chains. The EU imposes extremely strict standards on food additive market access, documentation, labeling and traceability; standard domestic products and basic document packages fail to meet these requirements, easily triggering customs clearance failures, detained goods and brand reputation damage with severe consequences.
HiSiaddi’s core competitive advantages lie in "comprehensive mastery of EU food regulations, abundant industry resources for ε-PL products and end-to-end compliance service capabilities": We deliver targeted solutions resolving four core challenges including regulatory classification adjustment, supplementary document provision, label revision and customs communication, eliminating all compliance risks within 72 hours to guarantee smooth goods release and establish long-term compliance mechanisms. We help clients break EU market access barriers, consolidate leading positions in high-end organic markets, mitigate compliance risks and enhance global brand competitiveness.
Please contact HiSiaddi customer service for further consultation on ε-polylysine product compliance issues.
+86-13120989737 
info@hisiaddi.com 
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