As a multi-purpose raw material for food, feed and pharmaceutical use, its compliance core lies in graded control and full traceability. Internationally, food grade shall meet EFSA (EU) and FDA (US) standards; pharmaceutical grade requires CEP/DMF and GMP certification. In China, food, feed and pharmaceutical grades shall comply with corresponding national standards respectively. Mecobalamin is limited to pharmaceutical use only and prohibited for ordinary food applications. Supplier qualifications shall be reviewed by grade; packaging and transportation shall adopt refrigeration and light-shielding protection according to grades. Strict control shall be imposed on impurities, microorganisms, GMO and irradiation risks. Contracts shall specify product grade, cold chain liability and full-chain traceability requirements.
EU: Food grade requires EFSA approval, E number assignment and compliance with EC 1333/2008; pharmaceutical grade requires CEP certificate and EDQM compliance.
US FDA: Listed as food additive under 21 CFR 172.190; feed grade requires FDA registration and FSVP verification; pharmaceutical API requires DMF filing and GMP compliance.
China: Food grade complies with GB 14880; feed grade complies with GB 7300.209; pharmaceutical grade complies with Chinese Pharmacopoeia 2025 Edition and GMP.
Special Control for Mecobalamin: Classified as a pharmaceutical ingredient in China, prohibited for ordinary food/health food use; imported mecobalamin raw materials are regulated as pharmaceuticals.
Food Grade: Business License (food additive), Food Production License, ISO 22000, FSSC 22000, HALAL/KOSHER (optional).
Feed Grade: Feed Production License, FDA Feed Registration, GMP.
Pharmaceutical Grade: Drug Production License, GMP, DMF (US)/CEP (EU), Pharmacopoeia-grade COA (≥99.5%).
General Documents: COA (content, related substances, heavy metals, microorganisms), MSDS, batch traceability records.
Packaging: 1kg/5kg/25kg aluminum foil bag / cardboard drum, light-proof, sealed and moisture-proof; refrigerated storage at 2–8℃ for pharmaceutical grade.
Labeling: Bilingual labeling including product name, CAS number, batch number, potency, purity, production date, validity period, storage conditions and production license number; pharmaceutical grade shall be marked with API, not for direct oral administration.
Transportation: Cold chain transportation for food/pharmaceutical grade at 2–8℃, light-proof and shockproof; cold chain records shall be provided.
Ingredient Compliance: Only cyanocobalamin/hydroxocobalamin are allowed for food grade; mecobalamin is strictly prohibited; active form shall be specified for pharmaceutical grade.
Strict Impurity Control: Heavy metals (Pb＜1ppm, As＜2ppm), microorganisms (sterile/total bacterial count), residual solvents (methanol ＜0.1%).
GMO / Irradiation: Non-GMO and non-irradiated; third-party test report shall be provided.
Clarify grade (food/feed/pharmaceutical), active form, potency standard, cold chain liability and full batch traceability.
Agree on recall, compensation and qualification guarantee liabilities for unqualified products failed in drug/food safety sampling inspection.
It is divided into plant extract (dietary supplement) and hydrochloride (pharmaceutical grade). The key compliance points are distinguishing product forms and avoiding medical efficacy claims. Internationally, dietary supplements shall meet GRAS (US) and THR (EU) requirements; pharmaceutical grade requires GMP and DMF/CEP certification. In China, berberine hydrochloride is defined as a pharmaceutical product requiring drug production qualifications, while berberine plant extract can be used as dietary supplement raw material. Suppliers shall provide grade-specific qualifications as well as pesticide residue and heavy metal test reports. Labels shall bear compliance reminders with medical claims strictly prohibited. Contracts shall specify product form, claim restrictions and liability for non-compliance.
EU: As dietary supplement raw material, no explicit EFSA approval required but compliant under Traditional Herbal Registration (THR); pharmaceutical grade requires CEP/GMP.
US FDA: Regulated as dietary supplement under DSHEA with GRAS recognition (Generally Recognized As Safe); medical treatment claims are prohibited; pharmaceutical API requires DMF/GMP.
China: Berberine hydrochloride is a pharmaceutical product (Berberine Tablet), and its API is regulated under pharmaceutical supervision (GMP, Production License); non-hydrochloride berberine plant extract can be used as dietary supplement raw material.
Promotion Red Line: Global prohibition of claiming as pharmaceutical products; dietary supplements can only be labeled with supporting metabolism / blood sugar health.
Plant Extract Grade (Dietary Supplement): Business License (plant extract / food raw material), ISO 22000, FSSC 22000, HALAL/KOSHER, pesticide residue / heavy metal test report.
Pharmaceutical Grade (Berberine Hydrochloride): Drug Production License, GMP, Chinese Pharmacopoeia/USP/EP grade COA (≥97%), DMF/CEP.
General Documents: COA (purity, related substances, pesticide residues, heavy metals, microorganisms), MSDS, botanical origin identification report.
Packaging: 25kg cardboard drum / 1kg aluminum foil bag, sealed, light-proof and moisture-proof, stored at room temperature.
Labeling: Bilingual labeling including product name, CAS number, batch number, purity, botanical origin, production date, validity period and storage conditions; pharmaceutical grade marked with API, not for direct use; dietary supplement grade marked with Non-pharmaceutical, no therapeutic effect.
Transportation: General chemical/food raw materials, light-proof, moisture-proof and high-temperature avoidance; cold chain is not required.
Ingredient Classification: Berberine hydrochloride = pharmaceutical product; free berberine extract = dietary supplement; mixed declaration is strictly prohibited.
Pesticide Residue / Heavy Metal: Pesticide residue ＜0.05mg/kg, Pb＜10ppm, As＜2ppm, Hg＜1ppm.
Microorganisms: Total bacterial count ＜1000cfu/g, mold ＜100cfu/g, no pathogenic bacteria detected.
Claim Compliance: Medical claims such as treating diarrhea/enteritis/lowering blood sugar are absolutely prohibited.
Clarify product form (extract/hydrochloride), purity standard, botanical origin, claim restrictions and batch traceability.
Agree on liability division, recall and compensation for violations confirmed by customs or drug regulatory authorities.
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