As a polymer additive, its compliance focuses on additive supervision and food contact scenarios. It enjoys polymer registration exemption under EU REACH, but SVHC screening (≤0.1%) and RoHS 2.0 compliance are required. Approved by US FDA for indirect food contact with a compliance letter required. Suppliers shall hold relevant polymer additive qualifications, ISO certifications and RoHS/FDA documents. Product heavy metal residues and food contact migration shall be strictly controlled; packaging shall be moisture-proof and light-shielding. Contracts shall specify compliance requirements and recall liabilities for non-conforming products. Detailed explanations are as follows.
EU REACH: Exempted from polymer registration, but monomer/impurity assessment is required; SVHC screening (≤0.1%) is mandatory.
EU RoHS 2.0: Full compliance (lead/cadmium/mercury/hexavalent chromium/phthalate-free) with RoHS test report provided.
US FDA: Approved under 21 CFR 178.2010 for indirect food contact (packaging/tableware), FDA compliance letter is required.
China: Comply with GB 38400 (RoHS) and GB 2760 (Food Contact); No mandatory license for industrial grade, MSDS/COA are required.
Business License (polymer additives / additives)
ISO 9001, ISO 14001; REACH Compliance Statement, RoHS Report, FDA Food Contact Letter.
GHS-standard MSDS, COA (active ingredient ≥98%, volatile matter ≤0.5%).
Packaging: 25kg paper bag / paper drum, moisture-proof and light-shielding, kept away from heat sources and UV rays.
Labeling: GHS standard + bilingual labeling, including product name, CAS number, batch number, purity, RoHS/FDA marking and storage conditions.
Transportation: General chemical goods with no UN number; Avoid exposure to sunlight, rain and high temperature.
Strict SVHC Control: Free of SVHC exceeding 0.1% (e.g. heavy metals, phthalates, polycyclic aromatic hydrocarbons).
Heavy Metal Residue: Pb＜10ppm, Cd＜1ppm, Hg＜1ppm (RoHS limit values).
Food Contact Migration: Overall migration ≤18mg/dm², specific migration ＜0.05mg/kg.
Clarify RoHS/FDA compliance, food contact grade, batch traceability and quality objection period.
Agree on recall and compensation liabilities for excessive SVHC or unqualified migration volume.
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.
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