Food Grade Calcium Carbonate (FCC): USP/FDA-certified, ≥99% purity, safe for pharmaceuticals, food fortification, and oral care. Heavy metals <1ppm.
Food Grade Calcium Carbonate (FCC) is a ultra-purified, edible-grade mineral specifically processed to meet stringent safety standards for human consumption. With ≥99% CaCO₃ purity, heavy metals <1ppm, and zero microbial contamination, FCC serves as a critical ingredient in pharmaceuticals, nutraceuticals, and food products.
Key Features:
Certifications: FDA 21 CFR 184.1409. EFSA, USP-NF, EU 10/2011.
Safety: Non-GMO, allergen-free, and Kosher/Halal certified.
Versatility: Neutral taste, fine particle size (D50 5–20μm), and excellent compressibility.
Raw Materials: Select limestone from quarries with geological purity reports (Fe₂O₃ <0.01%, SiO₂ <0.1%).
Exclusion Zones: Mining sites located away from industrial pollutants.
Steps:
Multi-Stage Washing: Remove impurities using deionized water.
Precision Milling: Jet mills produce 5–20μm particles (ISO 13320 compliant).
Sterilization: Gamma irradiation or heat treatment to meet USP <61> microbial limits.
Packaging: Nitrogen-flushed, food-grade polyethylene bags.
Quality Controls:
Heavy Metals: ICP-MS tested for Pb, Cd, As, Hg (<1ppm total).
Microbial: TAMC <100 CFU/g, TYMC <10 CFU/g (USP <2021>).
Parameter | Specification | Test Method |
CaCO₃ Purity | ≥99% | EDTA Titration |
Particle Size (D50) | 5–20 μm | Laser Diffraction |
Loss on Drying | ≤0.5% | USP <731> |
Heavy Metals | <1 ppm | ICP-MS |
Microbial Count | TAMC ≤100 CFU/g | USP <61> |
Customization: Adjust particle size (3–50μm), bulk density (0.4–0.8 g/cm³).
Pharma Compliance: Meets USP/EP for direct compression tablets (e.g., antacids, calcium supplements).
Food Safety: GRAS-affirmed, ideal for baking powders, dairy alternatives, and infant formula.
Tablet Binding: 20–30% FCC loading improves hardness (≥50 N) and disintegration (<15 mins).
Acid Neutralization: Rapid reactivity in antacids (pH adjustment within 2 mins).
Batch-specific COA with traceability to mine origin.
Supports FSSC 22000 and BRCGS audits.
Antacids: 500–1000 mg FCC per dose for fast acid neutralization.
Calcium Supplements: 99% bioavailability, compliant with USP <2021> dissolution standards.
Bakery Products: 1–2% FCC enhances dough stability (ISO 21415).
Plant-Based Milk: 120 mg Ca/100ml via FCC fortification (matches dairy milk).
Gummy Vitamins: 5–10% FCC as a calcium source without altering texture.
Powder Mixes: Free-flowing FCC prevents caking in protein supplements.
Toothpaste: Mild abrasive (RDA 40–60) for safe enamel polishing.
Mouthwash: pH stabilization with 0.5% FCC.
Global Approvals: FDA, EFSA, Health Canada NHP, JP (Japanese Pharmacopoeia).
Third-Party Testing: SGS reports for heavy metals, aflatoxins, and radioactivity.
Sustainability: RSPO-certified palm-free stearic acid (for coated FCC).
Q: How does FCC differ from industrial-grade CaCO₃?
A: FCC undergoes rigorous purification, sterilization, and heavy metal testing to meet edible standards.
Q: Can FCC be used in vegan products?
A: Yes, it’s mineral-based and compatible with vegan/plant-based formulations.
Q: What’s the shelf life of FCC?
A: 3 years in sealed packaging under <25°C and 60% RH.
Trust a Certified Calcium Carbonate Supplier:
Jintai, a leading calcium carbonate supplier, specializes in FCC for global food and pharma industries. Our FCC is produced in GMP-certified facilities with:
Pharma-Grade Lines: Meet USP/EP monograph requirements.
Custom Solutions: Tailored particle sizing, compaction aids, and coated FCC.
Regulatory Support: DMF/CEP filings and export certifications.
Request free samples and formulation guidance to elevate your edible products’ safety and performance.