Classification
Product TypeIngredient
Product FormPowder/Solid
Industry PositionFood Additive (Mineral Salt)
Market
Calcium gluconate is traded globally as a food additive and calcium-source ingredient, referenced in Codex as INS 578 and in the UK/EU E-number system as E578. Because customs statistics typically aggregate it within HS 291816 ("gluconic acid, its salts and esters"), trade flows should be interpreted as a proxy for calcium gluconate and related gluconates rather than a product-pure series. UN Comtrade data via WITS for HS 291816 indicates export supply is highly concentrated in China, with additional significant exporting countries including France, the Netherlands, India, and the United States. On the import side, major demand centers in recent reported data include India, the United States, Germany and other EU-linked entry points (e.g., Portugal), and Brazil, reflecting broad industrial and food-manufacturing usage across regions.
Major Exporting Countries- 중국Largest reported exporter by value/quantity for HS 291816 (gluconic acid, its salts and esters) in 2024 (UN Comtrade via WITS).
- 프랑스Major reported exporter for HS 291816 in 2024 (UN Comtrade via WITS).
- 네덜란드Reported major exporter for HS 291816 in 2024 (UN Comtrade via WITS); also a common EU logistics hub.
- 인도Reported major exporter for HS 291816 in 2024 (UN Comtrade via WITS).
- 미국Reported major exporter for HS 291816 in 2024 (UN Comtrade via WITS).
Major Importing Countries- 인도Largest reported importer by value/quantity for HS 291816 in 2024 (UN Comtrade via WITS).
- 미국Major reported importer for HS 291816 in 2024 (UN Comtrade via WITS).
- 포르투갈Reported major importer for HS 291816 in 2024 (UN Comtrade via WITS), potentially reflecting EU entry/distribution.
- 독일Major reported importer for HS 291816 in 2024 (UN Comtrade via WITS).
- 브라질Major reported importer for HS 291816 in 2024 (UN Comtrade via WITS).
Specification
Major VarietiesCalcium Di-D-Gluconate Monohydrate, Calcium Di-Gluconate, D-Gluconic acid, calcium salt (2:1)
Physical Attributes- White solid in various forms (dry ingredient).
- Moderate water solubility (reported as 3.5 g/100 mL at 25°C).
Compositional Metrics- CAS Registry Number: 299-28-5.
- Molecular formula: C12H22CaO14; molecular mass ~430.4.
- Melting point reported as 178°C.
Grades- Codex food additive: INS 578 (GSFA).
- UK/EU E-number designation: E578.
- United States: affirmed GRAS direct food substance in 21 CFR 184.1199, with Food Chemicals Codex specifications incorporated by reference.
ProcessingUsed for acidity regulation, firming, and sequestration in food formulations (Codex functional classes).
Supply Chain
Value Chain- Upstream gluconic acid production -> neutralization with lime (calcium hydroxide) or calcium carbonate -> purification/quality verification -> drying/milling -> distribution to food manufacturers and supplement producers.
Demand Drivers- Regulated functional use as an acidity regulator, firming agent, and sequestrant in Codex GSFA contexts.
- Use across broad Codex food categories under GMP (including prepared foods, ready-to-eat savouries, beverages, fermented milks, and food supplements).
- Use in the United States as a GRAS direct food substance with multiple technical effects (e.g., firming agent, sequestrant, stabilizer/thickener, texturizer) and as a nutrient supplement per FDA ingredient inventories.
Risks
Supply Concentration HighInternational trade for the HS 291816 grouping (gluconic acid, its salts and esters—which includes calcium gluconate) is heavily concentrated in China in recent reported UN Comtrade/WITS data. Disruptions affecting Chinese production capacity, compliance shutdowns, or export logistics can quickly tighten global availability and increase prices for calcium gluconate and related gluconates.Qualify multiple suppliers across key exporting origins (e.g., China plus EU and US/India suppliers), maintain dual sourcing and safety-stock policies, and use specification-based qualification (JECFA/FCC/Codex-aligned CoAs) to enable rapid switching.
Regulatory Compliance MediumAs a regulated food additive/ingredient (Codex INS 578; E-number E578; US GRAS listing with specified technical effects), non-alignment with jurisdiction-specific permissions, identity criteria, or labeling requirements can block market access and trigger recalls or border rejections.Maintain a jurisdiction-by-jurisdiction regulatory dossier (Codex GSFA + local rules), ensure labeling and use-level compliance, and align supplier documentation to recognized specifications (e.g., JECFA/FCC where applicable).
Food Safety MediumAs a mineral salt ingredient used across many food categories, quality deviations (incorrect identity/strength or unacceptable impurities) can affect food safety and functional performance, especially when used as a nutrient supplement or in beverages and dairy-type applications.Implement incoming testing and supplier audits, require lot-specific certificates of analysis, and verify identity and key quality parameters against recognized specifications referenced by regulators.
Sustainability- Industrial chemical/food-ingredient manufacturing impacts: energy use and effluent management associated with organic acid salt production and downstream drying.
Labor & Social- Worker health and safety in powder handling (dust exposure controls and hygiene practices) in manufacturing and repacking operations.
FAQ
What is the Codex identifier for calcium gluconate, and what does it do in foods?In Codex (GSFA), calcium gluconate is INS 578, and it is listed with functional classes including acidity regulator, firming agent, and sequestrant.
Is calcium gluconate permitted for use in foods in the United States, and for what technical effects?Yes. In the United States it is listed in 21 CFR 184.1199 as a GRAS direct food substance, with uses including firming agent, formulation aid, sequestrant, stabilizer or thickener, and texturizer (used under good manufacturing practice conditions).
Which countries are key exporters and importers for the trade grouping that includes calcium gluconate?For HS 291816 (gluconic acid, its salts and esters), WITS/UN Comtrade data for 2024 shows China as the leading exporter, with other major exporters including France, the Netherlands, India, and the United States; major importers include India, the United States, Germany, Portugal, and Brazil. This HS code covers multiple gluconates, so it should be treated as a proxy rather than calcium-gluconate-only trade.
How is calcium gluconate commonly manufactured according to US regulations?US regulation 21 CFR 184.1199 describes calcium gluconate as the calcium salt of gluconic acid that may be produced by neutralization of gluconic acid with lime or calcium carbonate.