E495 – Sorbitan monopalmitate | US status, genotoxicity and food uses

Quick analysis summary about E495 – Sorbitan monopalmitate food additive

Bottom line about E495

E495 is graded RED – UNSAFE under this site’s regulatory rules because the exact additive lacks standalone US authorization for direct addition to food, although it remains authorized in the European Union.

Why this grade for E495

The RED grade reflects US regulatory status, not proof of toxicity from permitted EU use. JECFA also made the group ADI temporary in 2026 because genotoxicity and global exposure data remain incomplete.[1]

Who may want to limit or avoid E495

Consumers who prefer additives authorized for direct food use in both the EU and US may avoid E495. Frequent consumers of several E491–E495 emulsifiers may also wish to limit combined intake.

Common uses and where E495 appears

E495 can emulsify fats and water in fine bakery wares, desserts, confectionery coatings, beverage whiteners, sauces, chewing gum, and food supplements.

E495 source or origin

E495 is a synthetic ester mixture made from sorbitol and commercial palmitic acid. The fatty-acid source may be vegetable or animal-derived.

Intake note for E495

JECFA established a temporary group ADI of 0–25 mg/kg body weight for E491–E495 in 2026. Its highest estimate was 24 mg/kg per day and may underestimate exposure in some Codex food categories.[1]

Is E495 banned anywhere?

The EU authorizes E495 in specified foods. The US does not list the exact substance for standalone direct food addition and identifies it only for specified indirect food-contact uses, which is non-approval for direct use rather than a blanket ban on every application.

Safety grading RED – UNSAFE

E495 receives RED because the exact additive does not have identified standalone US authorization for direct food use. This regulatory grade should not be read as evidence that permitted EU exposure has been proven harmful.

Study basis or key toxicological reasoning for E495

Direct E495 evidence is sparse and old. In a two-year study, 30 male rats received 5% sorbitan monopalmitate in the diet without treatment-related changes in growth, survival, blood findings, or examined organs.[2] The small single-sex design and limited reporting prevent this study from providing a modern robust NOAEL. EFSA instead used indirect group evidence. An 80-week study in 48 mice of each sex per group found no carcinogenic activity from sorbitan monostearate and a NOAEL of 2% in the diet, about 2,600 mg/kg body weight per day. Kidney enlargement and more nephrosis occurred at 4%.[3,4] EFSA applied read-across and concluded in 2017 that E491–E495 did not raise a genotoxicity concern.[3] JECFA reached a more cautious position in 2026 after available sorbitan monostearate studies indicated possible clastogenicity. It could not resolve the issue without additional EFSA-held data, withdrew the permanent group ADI, and established a temporary value.[1] Reproductive evidence is also indirect. Four-generation rat data on related emulsifiers found no adverse effects at 5% or 10% of the diet, while 20% impaired growth and lactation and increased liver and kidney weights.[2,5] A 2026 human biomonitoring study associated serum sorbitan monopalmitate with altered lipid profiles and flagged possible individual-level risk. Its cross-sectional design, mixed exposures, and uncertain source attribution prevent causal conclusions.[6]

Side effects of E495 – Sorbitan monopalmitate food additive

Emerging metabolic signal: A 2026 cross-sectional study linked serum sorbitan monopalmitate with lipid changes, but it cannot establish causation or identify the exposure source.[6]
Digestive discomfort at excessive intake: Very high amounts of related sorbitan esters caused diarrhoea and reduced growth in animals, which does not establish effects at normal food levels.[2]
Organ effects at extreme doses: Related esters produced kidney or liver changes at dietary concentrations far above typical additive exposure.[2,3,4]
Unresolved genotoxicity question: JECFA identified a possible chromosome-damaging signal for related E491 that requires clarification, not a proven E495 cancer effect.[1]
Combined exposure: Intake from several E491–E495 additives can approach the temporary group ADI in high-consumer estimates.[1,7]

Should You Avoid E495 – Sorbitan monopalmitate food additive?

US consumers should not interpret food-contact permission as authorization to add E495 directly to food. In the EU, it remains permitted in defined categories, but current genotoxicity, exposure, and biomonitoring uncertainties support a precautionary approach. Frequent consumers can limit products containing several sorbitan esters. Vegan, vegetarian, halal, or kosher consumers may need manufacturer confirmation because the palmitic-acid source can vary.

Common uses of E495 – Sorbitan monopalmitate food additive

Fine bakery wares: Helps distribute fat evenly and maintain a uniform texture.
Desserts and edible ices: Supports stable fat-and-water mixtures and smoother structure.
Confectionery and coatings: Controls fat crystallization and reduces separation.
Beverage whiteners: Keeps dispersed fat stable in powdered or liquid formulations.
Emulsified sauces: Helps prevent oil and water phases from separating.
Chewing gum and supplements: Functions as an emulsifier or formulation aid in permitted products.

Common names and synonyms of E495 – Sorbitan monopalmitate food additive

Sorbitan monopalmitate
Sorbitan palmitate
Span 40
Sorbitan monohexadecanoate
INS 495
E495

What is E495 – Sorbitan monopalmitate food additive?

E495 is a lipophilic emulsifier made by esterifying sorbitol and its dehydrated forms with edible commercial palmitic acid. The EU specification describes it as a mixture of partial sorbitol, sorbitan, and isosorbide esters rather than one perfectly pure molecule. It is usually a light cream to tan waxy solid and is insoluble in cold water but dispersible in warm water.

Its molecule contains a water-attracting sorbitan region and a fat-attracting palmitate chain. This arrangement lets it sit at the boundary between oil and water, helping a product remain mixed and influencing fat crystallization, aeration, and texture. Production usually involves controlled dehydration of sorbitol followed by esterification with palmitic acid and purification to food-grade specifications.

E495 is not polysorbate 40, which is the ethoxylated additive E434. It also has no official E495(i) or E495(ii) subtypes. Commercial source claims should be checked when plant or animal origin matters.

Where is E495 – Sorbitan monopalmitate food additive allowed (EU vs US)?

E495 is currently authorized in the European Union for specified food categories and maximum levels. No standalone US authorization for adding the exact substance directly to human food was identified. FDA lists sorbitan monopalmitate under 21 CFR 178.3400 for specified indirect food-contact applications.

E495 – Sorbitan monopalmitate