Sodium Gluconate Safety: GRAS, E576, and Gluten-Free

Your incoming-inspection team quarantines a drum of sodium gluconate. The supplier’s safety data sheet (SDS) flags it H302, harmful if swallowed, and quality control will not release a hazard-coded lot into a food line without sign-off. The lot is fine. The data sheet is not. That hazard line belongs to ferrous gluconate, a different salt with a different CAS number. Someone copied the wrong template, and a clean shipment sits on hold while the paperwork gets sorted.

Sodium gluconate occupies an awkward spot for procurement. It is one of the most benign chemicals you will buy, yet it draws the same repeat questions: is it safe to eat, is it gluten-free, is it the same thing as MSG.

The answers are settled and documented. The trouble is that the documentation is scattered across an FDA rule, an EU additive number, a Codex listing, and a PubChem record. This page pulls them into one place so you can answer an auditor or a formulator without guessing.

What sodium gluconate is

Sodium gluconate is the sodium salt of gluconic acid, a sugar acid produced by fermenting glucose. Its CAS number is 527-07-1 and its formula is C6H11NaO7, molecular weight 218.14 g/mol (PubChem CID 23672301). You will also see it labeled monosodium gluconate, sodium D-gluconate, or by its food-additive identity E576. It is a white-to-tan crystalline powder, highly soluble in water and sparingly soluble in ethanol.

Match the CAS on the label to 527-07-1 before anything else. A mismatch is the fastest way to catch a mislabeled or substituted lot, and it costs nothing to check on receipt.

What does GRAS mean for an incoming lot?

The FDA lists sodium gluconate as generally recognized as safe. The rule is short. 21 CFR 182.6757 states the substance “is generally recognized as safe when used in accordance with good manufacturing practice.” There is no numeric ceiling and no special handling instruction attached to it. The same substance appears at 21 CFR 582.6757 for animal feed use.

The hazard picture is equally quiet. In the ECHA Classification and Labelling inventory, surfaced through PubChem, 1,160 of 1,172 notifiers report that sodium gluconate meets no GHS hazard criteria. The compound carries no signal word, no pictogram, no hazard code. You still need an SDS on file, because OSHA’s Hazard Communication standard (29 CFR 1910.1200) requires one for every chemical in the workplace. Section 2 of an honest sodium gluconate SDS should read close to blank.

It helps to keep three regulatory frames separate, because each answers a different question. Food law (FDA GRAS, EU E576, Codex INS 576) asks whether it is safe to eat. Worker-safety law (OSHA HazCom and GHS) asks whether it is hazardous to handle. Transport law (DOT and IMDG) asks whether it is dangerous to ship. Sodium gluconate clears all three. PubChem assigns it no UN number, so it moves as general freight, not dangerous goods, and you should not see a hazmat surcharge on a quote.

Read Section 2 before you accept the lot. An H-code on a sodium gluconate SDS points to a copied template, not a real hazard, and the H302 lifted from ferrous gluconate in the example above is the common one. If you stock both gluconate salts, keep their data sheets physically separate so a clerk cannot grab the wrong one.

Is sodium gluconate gluten-free?

Yes, and the reason is structural. Gluten is a protein, the gliadin and glutenin complex from wheat, barley, and rye. Sodium gluconate is a single small molecule, C6H11NaO7, that contains no protein. There is no biochemical route for gluten to ride along in a purified gluconate salt.

The confusion is partly phonetic, since gluconate and gluten share three opening letters, and partly about feedstock. Commercial sodium gluconate is fermented from glucose, and that glucose is almost always corn-derived dextrose rather than wheat. Even where a wheat-starch glucose feedstock is used, the fermentation and purification steps remove protein, so the finished salt carries none.

FDA’s gluten-free labeling rule, 21 CFR 101.91, defines gluten-free as below 20 ppm gluten and explicitly covers ingredients that “inherently do not contain gluten.” Sodium gluconate sits in that category. For a finished product carrying a gluten-free claim, the 20 ppm limit applies to the food as a whole, so the gluconate’s own contribution is effectively zero.

For a gluten-free SKU, request a gluten statement and an allergen declaration with each lot, and have the feedstock named on it. The chemistry is settled, but a certifier under a food and beverage audit scheme wants the paper, not your explanation.

E576, INS 576, and the grade you buy

In the European Union the same compound is the food additive E576, and in the Codex Alimentarius system it is INS 576. Both classify it as a sequestrant, an ingredient that binds trace metal ions so they cannot catalyze oxidation, discoloration, or off-flavors. That is the food role. The same chelation does heavier work outside food.

Grade is where procurement gets burned. The molecule is identical across grades, but the specification and the impurity limits are not, and neither is the documentation. A USP or Food Chemicals Codex grade is built for beverages and supplements going into direct food contact. A technical grade, often 98 percent or better, goes into concrete admixtures and alkaline cleaners, plus water treatment, where heavy-metal limits and a gluten statement may never appear on the certificate.

Do not pay USP pricing for a water-treatment chelant, and do not drop a technical grade into a beverage line because the CAS matched. The grade, not the CAS, decides whether a lot is legal for your application.

How does it perform as a chelant?

Sodium gluconate’s working trait is chelation under alkaline conditions. In strong caustic, where many chelants drop out, it holds iron and calcium in solution. That single property explains most of where it ends up.

In food and beverage work the sequestrant role is narrow but real. Gluconate binds the trace iron and copper that drive rancidity and color loss, which protects flavor and shelf life in some beverages and dairy analogs. The dose is low, often a fraction of a percent, so the impact on a formula’s cost is small. In personal care the catalog lists a conditioning role, where the same chelation keeps metal ions from destabilizing a surfactant system or an emulsion.

The heavier duty is industrial. In HI&I cleaning it is the alkaline-stable chelant of choice for bottle washing and metal degreasing; caustic soda alone leaves scale, while a few percent of gluconate keeps calcium and iron dissolved so the rinse runs clean. In water treatment it controls scale and corrosion in cooling loops. In construction it acts as a set retarder and water reducer in concrete, which is why several trade synonyms point straight at the admixture market.

The handling numbers are forgiving. It melts at 170 to 175 C and has no boiling point at atmospheric pressure, instead decomposing at 196 to 198 C (PubChem). Density is 1.8 g/cm3, and a 10 percent solution sits at pH 6.5 to 7.5, close to neutral. There is no flash point, because the powder does not burn under normal conditions.

Against other sequestrants, the trade-off is biodegradability versus raw chelating strength.

If your formulation runs alkaline and needs a chelant that regulators and wastewater treatment will not fight you on, gluconate earns its place. If you need maximum chelation at neutral pH, EDTA is stronger, at the cost of biodegradability and tightening regulatory pressure.

How should you store and ship it?

Sodium gluconate is a hygroscopic powder, so it cakes if it draws moisture from the air. Keep it in sealed bags or lined drums, off the floor, in a dry warehouse, and reseal opened containers. Shelf life is long when it stays dry, because the salt is chemically stable below its decomposition point of 196 to 198 C (PubChem); confirm the exact figure on your supplier’s specification instead of assuming it.

Shipping is the easy part. Because PubChem assigns no UN number and the ECHA inventory records no GHS classification, the powder moves as general freight, not dangerous goods. There is no hazmat documentation, no placarding, and no surcharge tied to a hazard class. For a buyer modeling landed cost, that removes a line item that competing chelants such as some EDTA grades can carry.

The documentation a buyer should hold

For a food or pharmaceutical lot, request these with each shipment:

• Certificate of Analysis (CoA) against the USP or FCC monograph
• Safety data sheet (SDS) with a clear Section 2
• Gluten statement and allergen declaration that names the feedstock
• Heavy-metals and microbiological results where the monograph requires them
• Kosher, halal, or non-GMO letters if your customer specifies them

Hold these on file per lot, not per supplier. A supplier can switch its own raw-material origin between shipments, and the lot-level paper is what an auditor reads.

A sourcing desk earns its margin here. RawSource supplies sodium gluconate against the grade your application needs and ships the matching CoA and SDS plus a gluten and allergen statement with the lot, so an incoming-inspection hold like the one above never starts. Current grades sit on the sodium gluconate product page, and related procurement briefs are on the RawSource blog.

Sourcing note: physical properties and hazard data cited here are drawn from PubChem CID 23672301 and the ECHA Classification and Labelling inventory; regulatory language is quoted from the U.S. eCFR (21 CFR 182.6757 and 21 CFR 101.91), current as of 2026. No proprietary RawSource figures appear in this article.

RawSource Editorial

Commercial & Sourcing Desk