HiSiaddi is an innovative foreign trade service provider driven by dual engines of technology transformation and foreign trade services. It has established a "1+2+3+4=1" service system and can supply raw β-nicotinamide mononucleotide (β-NMN) sourced from multiple well-known original manufacturers. Possessing over a decade of market experience and technological transformation cooperation with factories, HiSiaddi boasts extensive experience resolving product compliance issues. Below is a case of HiSiaddi addressing compliance issues of β-NMN.
Contact HiSiaddi customer service for more consultation on β-NMN product compliance issues.
The purchasing partner is BIOHEALTH Holland Biotech Group based in Amsterdam, the Netherlands, a leading mid-to-high-end brand deeply engaged in high-end anti-aging dietary products across Western Europe. Its full product line is sold in premium AH chain supermarkets across the Netherlands, private wellness hospitals in Brussels, Belgium and organic cosmetic chains in Luxembourg, with two core product lines: high-purity single-ingredient NMN capsules and NMN-CoQ10 compound powder. Products strictly comply with five stringent compliance requirements: EU Novel Food new food regulations, EFSA raw material safety standards, German LFGB food contact material specifications, EU REACH chemical control regulations and Dutch NVWA food and drug administration access rules, targeting high-net-worth consumer groups across Western Europe. Previously, β-NMN raw materials were sourced from Swiss pharmaceutical-grade enzymatic raw materials with an annual stable procurement volume of 26 tons.
Faced with tight local biochemical raw material production capacity in Europe, successive 40% surges in raw material quotations and extended delivery lead times up to three months, the client launched China supply chain product selection and finalized an initial trial purchase order of 4.2 tons of β-NMN for mass production and launch of a new generation of high-end compound products. After independently sourcing goods from two domestic NMN manufacturers, five critical compliance hard defects emerged successively: incorrect HS code classification for customs declaration, missing EU Novel Food supporting dossiers, conflicts between product labels and regulations, raw material heavy metal & residual solvent internal control failing EU limits, and mismatched domestic export commodity inspection documents for Dutch customs clearance. Goods were nearly ready for shipment yet unable to complete customs declaration and outbound delivery. Delayed delivery would force the client to pay liquidated damages for new product breaches with supermarkets, and pre-determined Dutch local product filings faced rejection risks. In urgent circumstances, the client fully entrusted HiSiaddi Foreign Trade to handle full-process compliance rectification, document replacement, indicator rectification and customs clearance delivery.
Two raw material factories defaulted to classification under general chemical intermediates (HS 29362990) for declaration, while current domestic regulatory requirements stipulate β-NMN as a food dietary raw material eligible for compliant HS code 2936290090 (vitamin derivative, new food raw material category). Incorrect code classification triggers early warning in customs declaration systems, with customs judging inconsistent declared product names and product attributes to block normal commodity inspection and release. If misclassified goods are exported, Dutch customs will rule false declaration of commodity categories, leading to direct return of full container goods with comprehensive losses exceeding 300,000 EUR including one-way ocean freight, warehousing and liquidated damages. Factories lack dedicated import & export compliance specialists, primarily engaging in domestic raw material sales without familiarity with special NMN export classification rules.
EU regulations explicitly classify β-NMN as Novel Food (new food) not widely consumed in the EU prior to May 15, 1997. Importers must submit full raw material safety dossiers including toxicology test reports, 90-day animal feeding safety data, production process traceability documents and 60-day constant-temperature accelerated stability test reports to complete raw material filing with Dutch food and drug administration for legal shelf sales. Domestic factories can only provide conventional Chinese-English COA test slips without full new food declaration dossiers formatted per EFSA recognition standards. The client previously adopted dossier formats supporting Swiss original raw materials, yet domestic raw material document formats and test items are incompatible with EU specifications, stalling new product launch filings.
EU Regulation EC 2023/915 stipulates heavy metal limits for β-NMN: lead ≤0.038 mg/kg, arsenic ≤0.019 mg/kg, cadmium & mercury <0.002 mg/kg, with far stricter limits for organic solvent residues (methanol, ethanol etc.) than China’s national food standard EFSA. Samples tested from early factory batches only met domestic dietary raw material national standards, with trace cadmium exceeding limits and isopropanol residues surpassing EU control thresholds. Direct shipment would result in on-site inspection, seizure and destruction of goods by Dutch customs upon detection of non-compliance.
Domestic factories adopted generic chemical raw material labels marked only with Chinese product names and net weight, missing mandatory English information including raw material CAS number, maximum daily recommended dosage (EU limited to 300mg per day), applicable population warnings (pregnant & lactating women prohibited), manufacturer registration code, country of origin statement and allergen reminders. Inner bag PE materials lacked LFGB food contact material certification, leading EU customs to judge packaging non-compliant and ban entry for sub-packaging and production EFSA.
Dutch customs clearance mandates five mandatory documents: officially issued GSP Certificate of Origin FORM A, food-grade free sales certificate issued by local market supervision bureaus of factory locations, full-item English test reports from SGS EU-recognized laboratories and REACH-compliant SDS safety data sheets. Domestic factories can only provide self-made COA, with simplified free sales certificates issued by local industrial parks unrecognized by Dutch customs. SDS compiled per domestic chemical templates without updated latest REACH classification entries, with inconsistent product names, batch numbers and net weights across COA, bills of lading and packing lists, creating customs clearance risks.
1. HiSiaddi compliance specialists revised the customs declaration code to 2936290090 (food-grade nicotinamide derivatives) per detailed NMN supervision rules of China General Administration of Customs, reorganizing customs declaration elements: mark β-nicotinamide mononucleotide (dietary supplement raw material) as product name, clarify usage exclusively for EU dietary raw material processing, eliminate descriptions related to pharmaceutical or chemical intermediates to avoid misreported usage risks.
2. Coordinate third-party commodity inspection institutions to re-sample for commodity inspection, updating outbound goods release certificates to ensure fully consistent product names, specifications and batch numbers between release certificates and bills of lading, eliminating customs early warnings and obtaining legal customs declaration release qualifications.
1. HiSiaddi cooperated with domestic third-party testing institutions holding EFSA declaration qualifications to recompile full declaration dossiers per EU Novel Food Regulation (EU 2015/2283) drawing on factory existing production data: collate full production process traceability documents, full-component data from five mass production batches, 60-day constant-temperature accelerated stability test data and 90-day rat toxicology safety test summaries, all formatted in English aligned with EFSA filing standards.
2. Split dossiers into three sections: core raw material archives, safety assessment archives and finished product application archives, simultaneously assisting the client to submit pre-review applications to Dutch NVWA food and drug administration, with pre-review receipts confirming valid compliant dossiers to supplement statutory documents required for the client’s new product launch filing.
1. Deploy quality control engineers to reside at factories and guide refining & purification processes, optimizing recrystallization impurity removal procedures to re-purify batches exceeding limits via ion exchange purification to eliminate trace heavy metals and organic solvent residues.
2. Entrust SGS Netherlands cooperative laboratories recognized by the EU to conduct full-item retesting per EFSA standards covering four heavy metals, solvent residues, microorganisms (total bacterial count, Salmonella, Escherichia coli) and β-configuration content. All final indicators fell within EU statutory limits, with official English test reports filed as backup documents for port inspection in the Netherlands EFSA.
1. Replace inner packaging with LFGB food contact certified food-grade aluminum plastic composite films, and replace fiber drums with REACH-compliant EU moisture-proof cardboard.
2. Redesign bilingual Chinese-English labels per new EU food labeling regulations with complete mandatory information: CAS No. 1094-61-7, β-NMN, maximum daily recommended intake ≤300mg, unsuitable populations (pregnant/lactating women, minors), country of origin China, manufacturer code, no allergens, storage conditions and shelf life. All label content was pre-filed with Dutch food and drug administration for archiving EFSA.
1. Apply to China Council for the Promotion of International Trade for standardized GSP FORM A Certificate of Origin to enjoy preferential tariff treatment under China-Netherlands free trade agreement.
2. Assist factories to apply for official notarized food raw material free sales certificates from local market supervision bureaus.
3. Cooperate with chemical compliance institutions to update REACH-version SDS safety data sheets, unifying product names, batch numbers and net weights across COA, bills of lading, packing lists and certificates of origin without any text discrepancies. The full set of documents was archived for Dutch customs clearance.
After rectification, 4.2 tons of β-NMN raw materials were loaded on schedule and shipped from Shanghai Port to Rotterdam. After 35 days of ocean transportation, Dutch customs random sampling showed all indicators compliant, with full customs clearance completed within three working days relying on complete compliance documents without detention or liquidated damages. Raw materials were successfully put into mass production, and the client’s new compound NMN products were launched on premium supermarkets across the Netherlands, Belgium and Luxembourg as scheduled, with terminal sales volume rising by 32% year-on-year compared with the previous generation products in the first quarter after launch.
The client fully recognized HiSiaddi’s full-chain compliance service capacity, terminating original Swiss raw material procurement channels and signing an annual framework procurement agreement for 26 tons with balanced monthly shipments split into eight batches. HiSiaddi established an exclusive compliance archive, tracking real-time updates to EU EFSA and Dutch NVWA regulatory dynamics, conducting annual regular reviews of raw material standards, label specifications and filing documents to predict early changes to compliance policies. The client subsequently launched R&D of organic-certified NMN customized projects, fully entrusting HiSiaddi with full-process compliance declaration work.
Most domestic NMN raw material manufacturers focus on production and manufacturing, lacking dual-dimensional regulatory reserves covering China’s export commodity inspection and multi-country EU import compliance. They are only familiar with domestic product standards without understanding detailed EU Novel Food, LFGB, REACH and national food and drug administration access rules, easily triggering compliance loopholes across five links: code classification, labeling, testing, declaration and documents. Mid-to-high-end dietary brands in Europe and America are subject to dual strict compliance constraints by domestic drug regulatory authorities and premium chain supermarkets, with any raw material compliance defect directly leading to goods return, new product removal from shelves and huge liquidated damages for breach of contract.
Breaking the traditional intermediary model solely focused on raw material supply matching, HiSiaddi forms a one-stop closed-loop compliance service covering domestic export compliance rectification → raw material indicator compliance optimization → EU overseas filing dossier compilation → destination port full supporting customs clearance documents. It bridges the regulatory information gap between domestic factories and overseas clients, binding long-term repeat purchase demands from overseas mid-to-high-end brands relying on professional compliance capabilities.
Contact HiSiaddi customer service for more consultation on β-NMN product compliance issues.
+86-13120989737 
info@hisiaddi.com 
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