Polyoxyethylene sorbitan tristearate polysorbate 65
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Description
E436, also known as polysorbate 65 or polyoxyethylene (20) sorbitan tristearate, is a synthetic emulsifier used in the food industry to stabilize water and oil mixtures. It belongs to the polysorbate family, which are polyethoxylated sorbitan fatty acid esters. It is obtained by esterifying sorbitan with stearic acid, followed by the addition of ethylene oxide to form polyoxyethylene chains.
Industrially, the reaction is controlled to obtain a product with a degree of polymerization of approximately 20 ethylene oxide units per molecule. The result is a white or yellowish waxy solid, soluble in water and oils, with a melting point between 29 and 33 °C. Its main function is to reduce surface tension between phases, allowing the formation of stable emulsions.
In the European Union, E436 was authorized as a food additive after evaluations by EFSA (European Food Safety Authority) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). EFSA established an Acceptable Daily Intake (ADI) of 25 mg per kg of body weight per day, based on toxicological studies that showed no significant adverse effects. WHO also supports this ADI.
Globally, E436 is considered safe for human consumption at authorized levels. In food labeling, it must appear as 'polysorbate 65' or with its E number. Although it is a synthetic additive, its safety profile is widely accepted, and no serious side effects have been documented at the amounts used in foods.
E436 is mainly used as an emulsifier in bakery products, pastries, confectionery, ice cream, sauces, creams, and dairy products.
In the Spanish market, it is found in sliced bread, muffins, cookies, cream ice creams, mayonnaises, and margarines. Regulation EC 1333/2008 establishes maximum usage limits: for example, in fine bakery wares up to 10 g/kg, in ice cream up to 1 g/kg, and in emulsified sauces up to 5 g/kg. In the United States, the FDA classifies it as GRAS (Generally Recognized as Safe) for similar uses without specific limits, while in Japan it is permitted with restrictions similar to European ones.
The function of E436 is to improve texture, increase emulsion stability, and prevent ingredient separation.
Toxicological studies conducted by EFSA and JECFA have not identified significant adverse effects associated with the consumption of E436 at authorized doses. In animals, a slight increase in liver weight and changes in gut microbiota were observed only at very high doses (over 1000 mg/kg bw/day), far above the ADI. No carcinogenic, genotoxic, or teratogenic effects have been documented.
In humans, there is no evidence of specific allergic reactions to E436, although individuals sensitive to other polysorbates may experience mild digestive discomfort. No interactions with medications are known. EFSA concludes that E436 is safe for the general population, including children and the elderly, at current usage levels. WHO supports this conclusion.
- Polysorbate 65
- Polyoxyethylene (20) sorbitan tristearate
- Tween 65
- Polyoxyethylene sorbitan tristearate ester
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