E516 / Acidity regulators & anti-caking agents
Calcium sulfate
Safety in brief
Safe
Recorded EatMatrix rating, not a new clinical review. The amount, your sensitivities and country rules still matter.
- Watch for
- No allergen or sensitivity is recorded for this ingredient here. Check the whole product label; this is not an allergen-free guarantee.
- Our advice
- Read the whole food label and consider how often you eat the product. A name or E number does not tell you the amount, and an ingredient rating cannot assess the entire food.
What it is
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.
Dietary information
- Vegan
- Yes
- Halal
- Yes
- Gluten-free
- Yes
- Allergens
- None recorded
Recorded ingredient information. Check the product label or certification: sources, other ingredients and cross-contact can vary.
Research & body effects
Health notes from our ingredient record
- Generally recognized as safe at typical food-use levels; considered one of the more benign mineral additives.
Other references from our ingredient record
These links come from the original ingredient record. They are separate from the source reviews above and have not all been checked for the exact ingredient, amount consumed or claim. Dates are shown newest first.
- 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]
- 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 — EFSA Panel on Food Additives, EFSA Journal (2019). Official EFSA scientific opinion (bibliographic reference, imported 2026-10-13). It covers the additive as a group assessment and is not an individual human study; read the opinion for its findings.
Country rules
Country checks for E516
Permission depends on the market, type of food, amount and conditions. A scientific opinion or an E-number alone does not establish a legal use. These checks are separate from the stored EatMatrix rating.
Compare all eight markets and their sources
| Market | What is checked |
|---|---|
| European Union | Regulation (EC) 1333/2008, Annex II Part B, version , contains the exact code E516: Calcium sulphate. Listing alone does not allow every food use. Part E food categories, limits, specifications and applicable later acts still need a product-specific check. Source read: . |
| Great Britain | The FSA register record for E516 (Calcium sulphate) lists “Authorised” in England, Scotland and Wales. Register updated: 01 April 2025; record checked: . Food-specific conditions and specifications still need a separate legal check. |
| United States | Selected US conditions for Calcium sulfate Official federal text current through ; read . Food uses, limits and exceptionsNamed preparation and use conditions For the named functions, maximum levels as served are 1.3% in baked goods, 3% in confections/frostings, 0.5% in frozen dairy desserts/mixes and grain products/pasta, 0.4% in gelatins/puddings, 0.35% in processed vegetables and 0.07% or less in other categories. The specified food-grade preparation and good manufacturing practice are required. EatMatrix’s reading: a legal use condition answers where and how an ingredient may be used. It is not a test of your product, a personal safe intake or a claim that the ingredient benefits your body. Match the named substance, food and amount. Other federal provisions, food standards, state rules and later changes may also apply; this is a selected source review, not a complete product-compliance decision. |
| Northern Ireland | Review pending. Check the applicable EU rules and territory arrangements; the GB register alone does not establish this status. FSA guidance is a starting source, not a verified permission for this entry. |
| Canada | Named food-use records located. Health Canada lists the preparations below for specified foods and purposes. This is conditional permission for those uses, not approval of every product or a personal safety verdict. Only the named records and conditions below were located. Exact composition and specifications still need matching. Source tables captured . List publication dates are shown separately. Good Manufacturing Practice (GMP) is a condition of use, not an unlimited amount or a recommended intake. Food and Drug Regulations B.16.003 requires the listed source, purpose, amount and other conditions to match. The official consolidation read was current to 21 September 2026; product specifications and applicable later changes still need checking. Read 17 listed food-use conditionsCalcium SulphateHealth Canada: List of Permitted Emulsifying, Gelling, Stabilizing or Thickening Agents. List published ; item C.11.
Calcium SulphateHealth Canada: List of Permitted Firming Agents. List published ; item C.7.
Calcium SulphateHealth Canada: List of Permitted Food Additives with Other Purposes of Use. List published ; item C.12.
Calcium SulphateHealth Canada: List of Permitted Acidity Regulators and Acid-Reacting Materials. List published ; item C.14.
Calcium SulphateHealth Canada: List of Permitted Yeast Foods. List published ; item C.8.
EatMatrix reading: match the exact preparation and food first. A manufacturing limit is not an acceptable daily intake (ADI). A label without the amount cannot establish exposure, and an unlisted name here does not establish a ban. |
| Australia | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| New Zealand | Review pending. Food Standards Code permissions and conditions need an additive-specific check. FSANZ food-additive rules is a starting source, not a verified permission for this entry. |
| Japan | Review pending. The relevant list, identity and use standards need an additive-specific check. CAA food-additive lists is a starting source, not a verified permission for this entry. |
Sources & review status
Check what each source covers: an authority’s conclusion, a research finding and a country’s legal permission answer different questions.
What this guide covers
- Official assessment sources
- Commission-listed EFSA references for E516. Bibliographic identity checked; latest findings and current use rules need separate review.
- Original ingredient record
- 2 research links; newest recorded date: . Sources added separately to this guide are not included in this count.
This guide brings together our ingredient record and the dated sources shown here. Missing information describes a gap in this guide; it does not mean an ingredient is untested, safe or harmful. This is not a complete review of every study, preparation or current country rule. The amount in a product and how it is used still matter.
How to read the ratings, research and country checksAgency labels recorded by EatMatrix
These are imported database classifications, not verified current statements from each authority. Use the dated official sources below for their actual scope and conclusions.
| Authority | Database label |
|---|---|
| FDA | Safe |
| WHO | Safe |
| EFSA | Safe |
| FSANZ | Safe |
| Japan | Safe |
| UK FSA | Safe |
| Health Canada | Safe |
Official assessment sources for E516
The European Commission’s re-evaluation table lists official EFSA documents for this additive. Their identifiers and subjects were checked against publisher bibliographic records. A missing research link in the EatMatrix database does not mean the additive has never been assessed.
Name in the Commission table: Calcium sulphate.
- 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
EFSA scientific opinion. Published: .
These are assessment references, including historical or group assessments. They do not establish the latest scientific conclusion, a human health benefit or risk, or current permission to use the additive in a particular food. Later assessments, corrections and food-use conditions need separate review. The recorded EatMatrix rating above is unchanged.
European Commission re-evaluation table, status as of . EatMatrix checked this bibliography on .
Database updated: . What does an E number mean on a food label?
Common questions
Frequently asked questions
What is EatMatrix's recorded rating for E516?
The recorded EatMatrix rating for E516 (Calcium sulfate) is “Safe”. It is calculated from labels stored in our ingredient database. These labels are not verified current regulator decisions or country permissions. A database update date is not a scientific review date.
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 shows information and classifications recorded in our ingredient database. Current scientific and market-specific verification remains pending as described above. It is general information, not medical advice.