Polysorbate 60
A synthetic emulsifier that stops fats and water separating. Found in bakery products, coffee whiteners and dessert toppings.
EU regulators found insufficient data on whether polysorbates can damage DNA, and flagged a data gap that has not been formally closed. Lab and animal studies on related polysorbates suggest regular intake may alter gut bacteria composition.
What is it?
Polysorbate 60 is a synthetic compound made by reacting sorbitol (a sugar alcohol) with stearic acid (a fatty acid) and then treating the result with ethylene oxide. The 'polyoxyethylene' chains make it soluble in both water and fat. It belongs to the E432-436 polysorbate family, which are all structurally similar emulsifiers differing mainly in their fatty acid component.
What does it do?
It reduces surface tension between water and oil, allowing them to mix into a stable emulsion. In baked goods it interacts with starch and gluten to improve texture and extend shelf life. In non-dairy creamers and dessert toppings it keeps the fat dispersed evenly so the product pours or whips consistently.
Where you will see it
Non-dairy coffee creamers, aerosol and frozen dessert toppings, cake mixes, bakery fillings and icings, salad dressings, sauces, confectionery coatings, and some ice creams. On a label it appears as 'Polysorbate 60', 'polyoxyethylene sorbitan monostearate', or simply 'E435'.
What the science says
EFSA data-gap finding and genotoxicity uncertainty
When the European Food Safety Authority re-evaluated the polysorbate family (E432-436) in 2015, it found the existing data set was insufficient to rule out genotoxic potential. EFSA maintained the existing ADI but called for new genotoxicity studies to fill the gap. This is a formal regulatory flag, not a finding that genotoxicity has been demonstrated, but it means the question has not been answered to the authority's satisfaction.
EFSA's re-evaluation of polysorbates (E432-436 as a group) identified insufficient genotoxicity data and called for new studies before the data gap could be considered closed.
Gut microbiome: findings from related polysorbates
Most emulsifier-gut research has focused on polysorbate 80 (E433) and carboxymethylcellulose rather than polysorbate 60 directly. Studies using mouse models and in vitro gut models found that polysorbate 80 at elevated doses altered microbiome composition and increased intestinal permeability in ways associated with low-grade inflammation. Because polysorbate 60 shares the same backbone structure and is assessed in the same regulatory group, these signals are considered relevant, but direct human evidence for polysorbate 60 specifically is limited.
Polysorbate 80 and carboxymethylcellulose disrupted gut microbiota and promoted intestinal inflammation in mouse models at doses above typical dietary exposure.
An in vitro four-stage gut microbiota model showed increasing concentrations of polysorbate 80 and CMC altered microbiome composition and impaired epithelial integrity in a dose-dependent manner.
ADI and exposure
The Joint FAO/WHO Expert Committee on Food Additives set a group ADI of 0-25mg per kilogram of body weight per day for the polysorbate family. EFSA adopted the same figure. Estimated dietary exposure in European populations has generally been calculated to be well below this limit, though the data gap on genotoxicity means the ADI itself rests on an incomplete evidence base.
JECFA established a group ADI of 0-25mg/kg body weight per day for polysorbates, adopted by EFSA for E432-436.
Where it stands with the regulators
Who should be careful
People avoiding animal-derived ingredients should note that the stearic acid used to make polysorbate 60 is commonly sourced from animal fat (usually tallow), though plant-derived versions exist. Without explicit labelling there is no way to confirm the source. Look for 'E435' or 'polysorbate 60' on the label and contact the manufacturer if vegan status matters.
The honest read
The honest picture is that polysorbate 60 sits in a regulatory grey zone. It has been permitted in food for decades and dietary exposure is estimated to be below the agreed intake limit. However, that intake limit was set on data EFSA itself considered incomplete, specifically around whether the compound can interact with DNA. The gut microbiome evidence is primarily from the closely related polysorbate 80, not polysorbate 60 directly, and most studies used doses higher than typical food use. The science here is active and not settled.
Related additives
Common questions
Is E435 banned in the UK?
No. E435 (polysorbate 60) is an authorised food additive in the UK under the retained EU food additive regulations, permitted in a range of food categories.
Did EU regulators flag any concerns about polysorbate 60?
Yes. When EFSA re-evaluated the polysorbate family in 2015 it identified insufficient genotoxicity data and called for new studies before that question could be considered closed. This is a formal data gap, not a finding that harm has been shown, but it means the safety evidence base has a recognised hole in it.
What foods contain E435?
Non-dairy coffee creamers, aerosol dessert toppings, frozen dessert products, cake mixes, bakery fillings, salad dressings, confectionery coatings, and some dietary supplements. On a label it appears as 'E435', 'polysorbate 60', or 'polyoxyethylene sorbitan monostearate'.
Is E435 vegan?
Not reliably. The stearic acid used to make polysorbate 60 is commonly derived from animal fat. Plant-based versions using vegetable stearic acid exist but are not the industry default, and labels rarely specify the source. If vegan status matters, contact the manufacturer directly.
Sources
- UK FSA regulated products: E435 Polysorbate 60
- UK Food Standards Agency: Approved additives and E numbers
- EFSA ANS Panel: Re-evaluation of polyoxyethylene sorbitan monooleate (E 433), monostearate (E 435) and tristearate (E 436) as food additives (2015)
- Chassaing et al. — Dietary emulsifiers impact the mouse gut microbiota promoting colitis and metabolic syndrome, Nature (2015)
- Direct impact of commonly used dietary emulsifiers on human gut microbiota, Microbiome journal (2020)
- JECFA monograph on polysorbates (Group ADI 0-25mg/kg bw/day)
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