# Calcium Sulfate (E516) > Source URL: https://additivefacts.com/additives/calcium-sulfate > Markdown URL: https://additivefacts.com/additives/calcium-sulfate.md **Safety rating:** SAFE **E-number:** E516 **CAS number:** 7778-18-9 **Category:** stabilizer **FDA GRAS:** yes **Adverse events (FDA AERS):** 0 **FDA recalls:** 0 **Last updated:** 2026-04-04 ## Summary Calcium sulfate (CAS 7778-18-9) is a naturally occurring mineral compound approved as a food additive by the FDA with GRAS status. It functions primarily as a stabilizer, anticaking agent, and leavening agent in various food products, with multiple regulatory applications across food processing. ## Regulatory status | Country | Status | | --- | --- | | United States | approved | | European Union | not_evaluated | | United Kingdom | approved | | Canada | approved | | Australia | approved | | Japan | approved | | South Korea | approved | | Brazil | approved | | China | approved | | India | approved | ## Detailed analysis ## What is Calcium Sulfate? Calcium sulfate, also known as calcium sulphate or gypsum when in its dihydrate form, is an inorganic compound with the chemical formula CaSO₄. It occurs naturally in mineral deposits and seawater. In food applications, calcium sulfate is typically used in its anhydrous form (without water molecules) or as a dihydrate. The compound is white, odorless, and tasteless, making it suitable for use in foods without affecting sensory properties. ## Common Uses Calcium sulfate serves multiple functions in food manufacturing. As an anticaking agent, it prevents clumping in powdered products such as table salt and spice blends by absorbing moisture. In baking, it functions as a leavening agent, working with other ingredients to produce carbon dioxide gas that helps baked goods rise. The additive also acts as a drying agent in various food processing applications and serves as a processing aid in malting and fermentation processes for beer and other fermented beverages. Additionally, calcium sulfate is used as a pH control agent to maintain proper acidity levels, a nutrient supplement to fortify foods with calcium, and a firming agent in certain food preparations. It also functions as a formulation aid and lubricant or release agent in food manufacturing equipment. ## Safety Assessment Calcium sulfate has been designated as Generally Recognized As Safe (GRAS) by the FDA, indicating that experts have concluded it is safe for its intended uses in food. The extensive safety record reflects its natural occurrence and historical use in food production. According to FDA records, there have been zero reported adverse events associated with calcium sulfate as a food additive, and no recalls have been issued related to this ingredient. The compound is poorly absorbed in the human gastrointestinal tract, with most ingested calcium sulfate passing through the body unchanged. This characteristic limits systemic exposure and contributes to its favorable safety profile. The typical dietary exposure to calcium sulfate from food sources is well below levels that would raise safety concerns. Calcium sulfate is also recognized as safe by the European Food Safety Authority (EFSA) under the food additive regulations, with an established acceptable daily intake (ADI) of 80 mg/kg of body weight per day, indicating a substantial margin of safety. ## Regulatory Status In the United States, calcium sulfate is approved by the FDA for use as a food additive in numerous applications, with GRAS status confirming its safety for its intended purposes. It is regulated under 21 CFR Part 182 as a generally recognized as safe substance. Internationally, calcium sulfate is approved in the European Union under the food additive regulations (E516 designation in EU numbering). It is also approved in Canada, Australia, and most other countries with established food safety regulations. The widespread regulatory approval across multiple jurisdictions reflects the scientific consensus on its safety profile and its long history of safe use in food manufacturing. ## Key Studies Research on calcium sulfate has consistently demonstrated its safety profile. Toxicological studies have shown no evidence of carcinogenicity, mutagenicity, or reproductive toxicity at relevant food exposure levels. Studies examining absorption and elimination have confirmed that dietary calcium sulfate is poorly absorbed and readily excreted, limiting systemic exposure. The European Food Safety Authority's assessment concluded that calcium sulfate does not pose a safety concern for consumers at current exposure levels. Long-term consumption data from populations with higher dietary exposure to calcium sulfate compounds has not revealed adverse health effects. Historical use data spanning decades of food manufacturing provides additional evidence of safety, with no accumulation of safety signals in post-market surveillance. ## Brands using Calcium Sulfate - Bimbo (15 products) - Hot Pockets (14 products) - Nature's Own (8 products) - Sara Lee (8 products) - HOT POCKETS (5 products) - McKee Foods Corporation (5 products) - Bimbo Bakeries USA, Inc. (4 products) - Flowers Foods, Inc. (4 products) - Kemps LLC (4 products) - Safeway, Inc. (4 products) - Hostess Brands, LLC (3 products) - Jimmy Dean (3 products) - Lewis Bakeries Inc. (3 products) - The Kroger Co. (3 products) - Wal-Mart Stores, Inc. (3 products) - Ball Park (2 products) - Conagra Brands, Inc (2 products) - Fiber One (2 products) - H-E-B (2 products) - Kikkoman (2 products) - Middle East Bakery Inc (2 products) - Target Stores (2 products) - Tasty Baking Company (2 products) - Tyson Foods Inc. (2 products) - United States Bakery (2 products) - bimbo (2 products) - AdvancePierre Foods Inc. (1 product) - Ahold USA, Inc. (1 product) - Alpha Baking Co., Inc. (1 product) - American Bakers Cooperative (1 product) ## Sources - FDA Substances Added to Food (CFSAN) - OpenFDA Adverse Event Reporting System (AERS) - OpenFDA Food Recalls - EFSA OpenFoodTox - EU Food Additive Portal ## Citation Additive Facts. "Calcium Sulfate (E516) — Safety, regulation, and evidence." https://additivefacts.com/additives/calcium-sulfate. Accessed 2026-05-20.