About
Calcium sulfate is the calcium salt of sulphuric acid, occurring as an odourless white crystalline powder in anhydrous (CaSO4) or dihydrate (gypsum) form. It is used in food as a firming agent, flour treatment agent, sequestrant, yeast food, and mineral supplement.
Safety summary
EFSA's 2019 re-evaluation concluded that exposure to calcium sulfate at reported use levels does not raise a safety concern, with no numerical ADI required. JECFA similarly designates its ADI as 'not limited.' The only notable physiological threshold is a laxative effect observed in humans at approximately 300 mg sulphate/kg body weight per day, a level far exceeded by typical dietary exposure from food additive use.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | Authorised under Annex II and Annex III to Regulation (EC) No 1333/2008 as a firming agent, flour treatment agent, sequestrant, and yeast food. Also permitted as a mineral substance in foods for special medical purposes and total diet replacement for weight control under Regulation (EC) No 1925/2006 and Regulation (EU) No 609/2013. No numerical ADI established.source |
| Food Standards Agency (FSA) / Food Standards Scotland (FSS) (United Kingdom) | Approved | Authorised under Assimilated Regulation (EC) No 1333/2008 (retained in GB law post-Brexit) in Annex II and Annex III.source |
| FDA (Food and Drug Administration) (United States) | Approved | Affirmed as Generally Recognized as Safe (GRAS) under 21 CFR 184.1230 for use as a firming agent, leavening agent, nutrient supplement, pH control agent, and processing aid.source |
Who should approach with care
Research citations
- 1FDA. 21 CFR 184.1230 – Calcium Sulfate (GRAS Affirmation). accessdata.fda.gov
- 2EFSA. Calcium sulphate and reduction in body weight: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006, 2025. efsa.europa.eu
- 3EFSA. Re-evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, 514(i), 514(ii), 515(i), 515(ii), 516 and 517) as food additive, 2019. efsa.europa.eu
- 4PubMed. Re-evaluation of sulphuric acid and its sodium, potassium, calcium and ammonium salts (E 513, 514(i), 514(ii), 515(i), 515(ii), 516 and 517) as food additive, 2019. pubmed.ncbi.nlm.nih.gov
- 5WHO. JECFA Food Additive Details: Calcium Sulfate (INS 516), 1975. apps.who.int
