About
Monocalcium phosphate (Ca(H₂PO₄)₂) is the monobasic calcium salt of phosphoric acid, widely used as a leavening agent, acidity regulator, and flour treatment agent in baked goods and processed foods. When combined with sodium bicarbonate, it releases carbon dioxide during baking to improve dough rise and texture.
Safety summary
EFSA's 2019 re-evaluation confirmed that phosphates including E341(i) are of low acute oral toxicity with no genotoxicity or carcinogenicity concern, and established a group ADI of 40 mg phosphorus/kg body weight/day. Total dietary phosphate exposure from food and supplements combined may exceed this ADI for heavy consumers, posing risks to kidney function. Individuals with moderate-to-severe kidney disease are explicitly identified as a vulnerable population for whom the ADI does not apply.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Approved | ADI of 40 mg/kg bw/day expressed as phosphorus (equivalent to ~2.8 g phosphorus/day for a 70 kg adult). Authorised under Regulation (EC) No 1333/2008, Annex II and III. EFSA 2019 re-evaluation confirmed safety at current use levels but recommended introduction of numerical maximum permitted levels for food supplements. ADI does not apply to persons with moderate-to-severe kidney disease. Maximum permitted food-use levels range from 500 to 20,000 mg/kg depending on food type. EFSA also called for characterisation of nanoparticle content in E341(i) specifications.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Approved as INS 341(i) (Monocalcium orthophosphate) under Food Safety and Standards (Food Products Standards and Food Additives) Regulations 2011. Maximum levels are expressed as combined phosphorus content; e.g. 440 mg/100g (singly or in combination with other phosphates) for certain product categories. Version II compendium dated 04.01.2024.source |
| FDA (Food and Drug Administration) (United States) | Approved | Listed as GRAS (Generally Recognized As Safe) under 21 CFR 182.1217 for use as a nutrient supplement and functional ingredient in food. No specific ADI set by FDA.source |
Who should approach with care
Research citations
- 1FDA. 21 CFR 182.1217 – Calcium phosphate, monobasic (GRAS listing). accessdata.fda.gov
- 2FSSAI. Food Safety and Standards (Food Products Standards and Food Additives) Regulations – Compendium Version II (04.01.2024), 2024. fssai.gov.in
- 3PubMed. On the Application of Calcium Phosphate Micro- and Nanoparticles as Food Additive, 2022. pmc.ncbi.nlm.nih.gov
- 4EFSA. Re-evaluation of phosphoric acid–phosphates – di-, tri- and polyphosphates (E 338–341, E 343, E 450–452) as food additives and the safety of proposed extension of use, 2019. efsa.europa.eu
- 5PubMed. Re-evaluation of phosphoric acid-phosphates – di-, tri- and polyphosphates (E 338–341, E 343, E 450–452) as food additives and the safety of proposed extension of use, 2019. pubmed.ncbi.nlm.nih.gov
- 6EFSA. EFSA issues new advice on phosphates (press release), 2019.
