E516 · Calcium sulfate
- WHO
- Safe
- FDA
- Safe
- EFSA
- Safe
- FSANZ
- Safe
- Japan
- Safe
- UK FSA
- Safe
- Health Canada
- Safe
What is E516?
Calcium sulfate (E516), also known as gypsum, is used in food production as a firming agent, coagulant, and dough conditioner. It is best known as the traditional coagulant used to set tofu and is also used in some baked goods and as a calcium-fortification source. It is generally recognized as safe by both EFSA and the FDA.
Also appears on labels as: Calcium sulfate, E516, E 516, E-516, Calcium sulphate, Gypsum, Plaster of Paris, Anhydrous calcium sulfate, Dihydrate calcium sulfate, Calcium sulfate anhydrite, Food additive E516, Kalcio sulfatas.
What the evidence says
- Generally recognized as safe at typical food-use levels; considered one of the more benign mineral additives.
Research behind the verdict
- Calcium Sulfate in Foods: Safety Profile and Regulatory Compliance Assessment — Elchemy Regulatory Compliance Team, Food Safety and Regulatory Compliance Journal (2024). A comprehensive 2024 safety assessment of calcium sulfate (E516) examining its uses as a firming agent, stabilizer, dough conditioner, and calcium supplement in foods. The study confirmed calcium sulfate is generally recognized as safe (GRAS) by the FDA and approved by international regulatory bodies. The research found it to be non-toxic at typical usage levels and well-tolerated by consumers. The assessment noted its natural occurrence as the mineral gypsum and confirmed its safety for various food applications including tofu, cheese, baked goods, and beverages.[safe]
Frequently asked questions
Is E516 safe?
Our overall verdict for E516 (Calcium sulfate) is “Safe”, based on the most cautious of the major regulators’ positions — FDA: safe; WHO: safe; EFSA: safe; FSANZ: safe; Japan: safe; UK FSA: safe; Health Canada: safe.
Is E516 vegan, halal or gluten-free?
According to our ingredient data for Calcium sulfate — vegan: yes, vegetarian: yes, halal: yes, kosher: yes, gluten-free: yes, dairy-free: yes. Manufacturing sources can vary between products; check the label if it matters to you.
What is E516 and why is it used?
Calcium sulfate (E516), also known as gypsum, is used in food production as a firming agent, coagulant, and dough conditioner. It is best known as the traditional coagulant used to set tofu and is also used in some baked goods and as a calcium-fortification source. It is generally recognized as safe by both EFSA and the FDA.
Does E516 contain allergens?
No known allergens are recorded for Calcium sulfate.
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This page summarises publicly available regulatory assessments and research. It is general information, not medical advice. Sources: EFSA, FDA, WHO and the studies linked above.