Calcium Acetate E263: Food-Use and Regulatory Boundaries

E263 is the European food-additive number for Calcium Acetate, CAS 62-54-4. The E-number identifies a regulated substance entry; it does not mean every Calcium Acetate lot is food grade, every food category is permitted or every destination market follows the same conditions. Buyers should match the jurisdiction, food category, technical function, material form, regulatory specification and current supplier evidence before qualification.

What does E263 identify?

For formula, molecular-weight, hydrate and sourcing details, see the Calcium Acetate formula, properties and sourcing guide.

EU E263 identity and purity context

Commission Regulation (EU) No 231/2012 provides the specifications for E263. The values below describe that regulatory entry. They are not a current Longchang specification, COA, grade declaration or promise that a particular lot complies.

EU food-use conditions are category-specific

The consolidated Regulation (EC) No 1333/2008 includes E263 in the EU food-additives framework and lists conditions by food category. “Quantum satis” does not mean unlimited or automatically suitable: the additive must still be authorized for the exact category, used according to good manufacturing practice and meet the applicable specifications and other legal requirements.

For processed cereal-based foods and baby foods, the consolidated text lists E263 at quantum satis only for pH adjustment. The old product page’s fixed infant-food dosage was not supported by that current EU entry and is not retained. Buyers must verify the current consolidated legislation, exact category and destination-market interpretation at the time of use.

U.S. 21 CFR 184.1185 scope

U.S. 21 CFR 184.1185 identifies Calcium Acetate as a direct food substance affirmed as GRAS under specified conditions. It lists technical effects including firming agent, pH-control agent, processing aid, sequestrant, stabilizer/thickener and texturizer. The rule uses current-good-manufacturing-practice conditions and gives maximum levels as served for named categories.

These U.S. regulatory values are not universal global permissions, formulation advice or a Longchang product specification. The buyer remains responsible for confirming the current rule, technical effect, food category, use level and all applicable requirements.

How to qualify Calcium Acetate for a food application

1. Identify the destination country or region and the exact food category.
2. Define the intended technical function rather than relying on a generic “food use” label.
3. Confirm that Calcium Acetate/E263 is authorized for that category and function under the current rules.
4. Define whether anhydrous or monohydrate material is required and the assay calculation basis.
5. Build the buyer specification from the applicable regulatory standard, process risks and finished-food requirements.
6. Request the current supplier specification, methods, applicable lot COA, SDS and required regulatory statements.
7. Validate the material and use level in the buyer’s formulation, quality system and compliance process.

Finished Calcium Acetate medicines are a separate product category

DailyMed lists named Calcium Acetate capsules as finished prescription phosphate binders. Those records apply to specific finished dosage forms, strengths, labels and approvals. They do not establish that a CAS 62-54-4 raw material is pharmaceutical grade, approved for a drug product or suitable for patient use.

This supplier page does not provide treatment, dosage, contraindication, pregnancy, interaction, side-effect or comparative-efficacy guidance. Finished-drug decisions belong to the approved label, healthcare professionals and the relevant regulatory framework.

Claims that require current supplier evidence

A buyer should not treat “high purity,” “food grade,” “pharmaceutical grade,” “meets international standards,” “COA/MSDS available,” “reliable supply,” “global shipping” or similar legacy wording as established facts. Request current controlled evidence for the exact material, site, specification, lot and quotation.

• Controlled product name, material form and manufacturing site.
• Current specification number/version and analytical methods.
• Applicable lot COA with units and form/assay basis.
• Current SDS and destination-specific classification information.
• Requested food-regulatory, allergen, origin or quality statements where applicable.
• Current sample, MOQ, packaging, availability and destination-specific lead time.

Request current Calcium Acetate qualification information

Open the Calcium Acetate CAS 62-54-4 sourcing page and state the jurisdiction, food category, technical function, material form, target specification, quantity and destination.

E-Mail info@longchangchemical.com to request current documents and commercial confirmation.

Frequently asked questions

Is Calcium Acetate E263?

Yes. E263 is the EU food-additive number for Calcium Acetate, but the exact conditions of use still depend on the food category and applicable legislation.

Does E263 mean every CAS 62-54-4 lot is food grade?

No. The substance identity and E-number do not prove that a particular material meets the applicable regulatory specification or buyer requirements.

Is Calcium Acetate approved for any amount in any food?

No. Requirements are jurisdiction- and category-specific. “Quantum satis” operates within the applicable authorization and good-manufacturing-practice conditions.

Does a finished Calcium Acetate capsule label prove raw-material drug grade?

No. A finished prescription product’s label and approval do not automatically apply to an unspecified raw material.