Polyoxyethylene sorbitan monostearate polysorbate 60
Score impact
0.00
points/product
Description
The food additive E435, known as Polysorbate 60 or polyoxyethylene sorbitan monostearate, is an emulsifier widely used in the food industry. It belongs to the group of polysorbates, which are ethoxylated sorbitan esters. It is obtained industrially by reacting sorbitol with stearic acid to form sorbitan monostearate, which is then ethoxylated with ethylene oxide. The result is a mixture of partial esters of sorbitan and its anhydrides, with a polyoxyethylene chain.
Physically, it is a viscous liquid or semisolid from yellow to amber, soluble in water and oils, which gives it exceptional emulsifying properties. Its main function is to stabilize water and oil emulsions, preventing phase separation. It also acts as a dispersant and texturizing agent.
Historically, polysorbates were developed in the 1930s and approved in the European Union as safe food additives. The European Food Safety Authority (EFSA) has evaluated E435 on several occasions, establishing an Acceptable Daily Intake (ADI) of 25 mg/kg body weight. The World Health Organization (WHO) has also evaluated it, confirming its safety at authorized doses.
The overall safety assessment is favorable, considering it a safe additive for consumers when used within established limits. On food labels, it must appear as 'E435' or 'Polysorbate 60'.
E435 is used in a wide variety of food categories as an emulsifier, stabilizer, and texturizing agent. According to EC Regulation 1333/2008, it is authorized in bakery and pastry products (e.g., sliced bread, muffins), dairy products (ice cream, custards, yogurts), sauces and dressings (mayonnaise, vinaigrettes), beverages (smoothies, milk drinks), confectionery (chocolates, candies), and processed meat products.
In the Spanish market, it is found in brands such as Bimbo (sliced bread), Danone (yogurts), Gallo (mayonnaise), and Nestlé (ice cream). Maximum limits vary by product, from 1 g/kg in bakery to 10 g/kg in emulsified sauces. Comparatively, the US FDA also approves it as GRAS (Generally Recognized as Safe) with similar limits, while in Japan its use is permitted with additional restrictions in certain foods.
Toxicological studies have shown that E435 is safe at authorized doses. EFSA and WHO have evaluated its acute, subchronic, and chronic toxicity, finding no significant adverse effects in humans. In animal studies, very high doses (far above the ADI) have shown mild laxative effects and alterations in gut microbiota, but these are not considered relevant for normal human exposure.
No carcinogenic, genotoxic, or teratogenic effects have been documented. Sensitive populations, such as people with inflammatory bowel diseases, could experience digestive discomfort with very high consumption, but there is no conclusive evidence. No interactions with medications are known.
The conclusion of EFSA and WHO is that E435 does not pose a health risk when consumed within established limits. The ADI of 25 mg/kg body weight is widely safe, as the estimated intake in the general population is well below this value.
- Polysorbate 60
- Polyoxyethylene sorbitan monostearate
- POE (20) sorbitan monostearate
- Tween 60
Classification:
Statistics
16
total views
Something wrong?
If you notice incorrect or incomplete information, help us improve the platform.