Other names for the additive (synonyms)
General Information
Additive E433 (polyoxyethylene sorbitan monooleate), more commonly known as Polysorbate 80 or Tween 80, belongs to the class of non-ionic surfactant emulsifiers. In the food industry, it functions as a stabilizer, emulsifier, and solvent for flavorings and colorants — particularly effective in oil-in-water mixtures.
Polysorbate 80 does not occur naturally — it is a fully synthetic compound, a mixture of partial sorbitan esters, its dianhydrides, and oleic acid. It was developed in the first half of the 20th century as a derivative of polyethoxylated sorbitan esterified with food-grade oleic acid.
The industrial production of additive E433 is based on the ethoxylation of sorbitan followed by esterification. Strict purity standards and controlled ethoxyl group content are maintained to minimize residual harmful impurities in the final product.
Physically, E433 is a viscous amber-yellow liquid, fully soluble in water and alcohols. Chemical formula: Polysorbate 80 — C64H124O26.
Effects on the Body
Benefits of Additive E433
Polysorbate 80 is not a natural component of the human body and does not provide any direct health benefits. In pharmaceuticals, additive E433 is used as a solvent and stabilizer, enhancing the bioavailability of active ingredients.
Risks of Additive E433
Most toxicological studies indicate that even at doses far exceeding the ADI, no acute lethal effects from additive E433 consumption have been observed. However, mice showed hyperplasia and inflammation of the gastric mucosa, and rats exhibited minor adrenal tumor growth.
Clinical cases show that, rarely, sensitive individuals may experience allergic reactions to Polysorbate 80, including anaphylaxis, contact pruritus, and urticaria — especially upon parenteral administration.
In one study, intradermal tests with 0.005% polysorbate 80 solution produced false-positive reactions in 77% of subjects at 0.05 ml injection.
Zebrafish (Danio rerio) studies indicate that the composition and origin of polysorbate components affect toxicity: some isolated components (PIM, PSM, PSD) caused significantly higher lethality and hemolysis than standard samples, highlighting the need for quality control.
Additionally, several studies suggest that Polysorbate 80 can alter gut microbiota composition. These changes may contribute to the development of inflammatory bowel diseases (IBD) and Crohn’s disease.
Overall, however, many regulatory bodies do not consider additive E433 to pose a health risk when used within established limits. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) established a group acceptable daily intake (ADI) for polysorbates at 25 mg/kg body weight during its independent evaluation in 1973.
The European Food Safety Authority (EFSA) reaffirmed the low toxicity and lack of carcinogenicity or mutagenicity of polysorbates in its 2015 re-evaluation, confirming the ADI at 25 mg/kg body weight.
Uses
In the food industry, additive E433 is a key emulsifier that prevents fat-water separation and stabilizes product structure. It is widely used in ice cream at up to 0.5% to improve texture and prevent melting. Additive E433 is also applied in chewing gum, dairy products, sauces, confectionery, and creams.
In cosmetics, Polysorbate 80 is found in lotions, gels, decorative cosmetics, and shampoos. In pharmaceuticals, it is used in injectable solutions, eye drops, vaccines, and capsules as a stabilizer and solvent.
Legal Status
Additive E433 is authorized for use in the food industry in many regions. In the EU, it is included in Regulation (EU) No. 1333/2008, listing permitted food additives. In Ukraine, following EU legislation, additive E433 is also allowed in food products with the ADI of 25 mg/kg.
In the USA, the FDA classifies Polysorbate 80 as GRAS (Generally Recognized As Safe) when used according to specified guidelines. In Canada and Japan, E433 is similarly permitted in food products with comparable dosage and compositional requirements.