Maleic acid | whatsinit

About

What it is and where it shows up.

Maleic acid is an unsaturated dicarboxylic acid (the cis-isomer of butenedioic acid) used industrially as a chemical intermediate, notably in the synthesis of malic acid and fumaric acid. It is not approved as a direct food additive in any major jurisdiction and is controlled as a trace impurity in permitted acidity regulators such as DL-malic acid (INS 296).

Safety summary

The regulatory and scientific consensus.

Maleic acid is not authorised for intentional use as a food additive by FDA, EFSA, or FSSAI; its presence in food is limited to trace impurity levels in other approved acids (e.g., ≤0.05% in malic acid per JECFA specifications). Animal studies indicate nephrotoxic potential at higher doses, and there is no established ADI for deliberate dietary intake. Sensitive populations including those with pre-existing kidney disease face the greatest risk from any inadvertent exposure above trace levels.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
FSANZ (Food Standards Australia New Zealand) (Australia)	Banned	Maleic acid is not listed as a permitted food additive in the Australia New Zealand Food Standards Code.source
EFSA (European Food Safety Authority) (European Union)	Banned	Maleic acid does not appear in the EU list of authorised food additives under Regulation (EC) No 1333/2008; it is controlled solely as an impurity in authorised substances such as malic acid (E 296). No E-number has been assigned.source
FSSAI (Food Safety and Standards Authority of India) (India)	Banned	Maleic acid does not appear in FSSAI's permitted food additives list (Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011). Its use as an adulterant in starch-based foods has prompted FSSAI enforcement action.source
FDA (Food and Drug Administration) (United States)	Banned	Maleic acid is not listed as GRAS or as an approved direct food additive under 21 CFR. It appears in FDA documents only as a precursor chemical in malic acid manufacturing, not as an intentional ingredient.source

Who should approach with care

Whose guidance would steer them away.

Kidney Disease — Animal and human data from maleic acid adulteration incidents demonstrate proximal tubular nephrotoxicity; individuals with pre-existing kidney disease face heightened risk of acute kidney injury even at lower exposures.

Children — Cases of maleic acid food adulteration (notably in starch-based products popular with children) have resulted in renal injury in paediatric populations, with children being disproportionately affected due to higher relative intake per body weight.

Pregnancy — No safety data exist for deliberate maleic acid intake during pregnancy, and its nephrotoxic potential poses unacceptable risk to both the mother and foetus; no approved dietary use exists in any jurisdiction.

Liver Disease — Metabolic processing of organic acids including maleic acid may be impaired in individuals with liver disease, potentially increasing systemic exposure and associated toxicity.

Elderly — Age-related decline in renal function makes older adults more susceptible to the nephrotoxic effects associated with maleic acid exposure above trace impurity levels.

Research citations

The sources behind this verdict.

1EFSA. Call for data for the re-evaluation of malic acid and malates (E 296; E 350–352) as food additives. efsa.europa.eu
2PubChem / NIH. Maleic Acid | C4H4O4 | CID 444266. pubchem.ncbi.nlm.nih.gov
3PubMed / EFSA Novel Foods Panel. Evaluation of di-magnesium malate as a novel food ingredient — PMC, 2020. pmc.ncbi.nlm.nih.gov
4PubMed. Maleic acid adulteration of starch — nephrotoxic effects and regulatory implications, 2019. pubmed.ncbi.nlm.nih.gov
5WHO/JECFA. DL-Malic Acid — JECFA Monograph (67th JECFA, 2006), FAO JECFA Monographs 3, 2006. fao.org

Independently researched5 citations