Polyoxyethylene sorbitan monooleate polysorbate 80
Score impact
0.00
points/product
Description
The food additive E433, known as polyoxyethylene sorbitan monooleate or polysorbate 80, is an emulsifier widely used in the food industry. It belongs to the polysorbate family, which are polyethoxylated sorbitan esters. It is obtained by esterifying sorbitan (derived from sorbitol) with oleic acid, followed by the addition of ethylene oxide.
Industrially, it is produced from vegetable sources (olive or palm oil) or synthetically. It is a viscous liquid ranging from yellow to orange, soluble in water and oils, with a hydrophilic-lipophilic balance (HLB) of 15, making it effective for stabilizing oil-in-water emulsions. Its main function is to prevent phase separation in products such as ice cream, mayonnaise, sauces, bakery products, and beverages. It is also used as a dispersing and wetting agent.
Historically, it was approved in the European Union as a food additive after evaluations by the Scientific Committee for Food (SCF) and subsequently by the European Food Safety Authority (EFSA). EFSA has reassessed its safety several times, establishing an Acceptable Daily Intake (ADI) of 0-25 mg/kg body weight. The World Health Organization (WHO) has also evaluated it, confirming its safety at authorized doses. Regarding labeling, it must appear as 'polysorbate 80' or 'E433' in the ingredient list.
Globally, it is considered a safe additive for the general population, although moderation in the consumption of processed foods is recommended. However, some animal studies have suggested possible effects on gut microbiota at very high doses, but without relevance for normal human exposure. In the EU, its use is regulated by Regulation (EC) 1333/2008, which sets maximum limits for each food category.
E433 is mainly used as an emulsifier in a wide variety of foods. In the European Union, it is authorized in numerous categories according to Regulation (EC) 1333/2008. For example, in ice cream and dairy desserts, it is allowed up to 1 g/kg; in emulsified sauces (such as mayonnaise), up to 5 g/kg; in fine bakery products, up to 3 g/kg; in flavored dairy drinks, up to 0.5 g/kg; and in food supplements, up to 5 g/kg.
In the Spanish market, it is found in ice creams from brands like Nestlé or Frigo, in mayonnaises like Hellmann's or Ligeresa, in salad dressings, in industrial pastries like Donuts or Panrico, and in fortified plant-based beverages. It is also used in the cosmetic and pharmaceutical industries. Comparatively, the US FDA classifies it as GRAS (Generally Recognized as Safe) and allows its use in foods without specific limits, provided it complies with good manufacturing practices. In Japan, it is also approved with limits similar to European ones.
The versatility of E433 is due to its ability to stabilize emulsions and improve texture, preventing ingredient separation.
Documented side effects of E433 are scarce and generally mild. EFSA and WHO have concluded that, at authorized doses, it poses no risk to human health. However, some animal studies have observed that very high doses (far above the ADI) can cause diarrhea, alterations in gut microbiota, and changes in intestinal permeability.
In humans, no significant adverse effects have been reported with normal consumption. There is some controversy regarding its possible role in intestinal inflammation, but human studies are limited and inconclusive. Sensitive populations, such as people with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD), might experience digestive discomfort if they consume large amounts of processed foods containing this additive, although there is no direct evidence.
No interactions with medications are known. EFSA, in its 2015 re-evaluation, established an ADI of 25 mg/kg/day, based on a NOAEL (no observed adverse effect level) of 2,500 mg/kg/day in rat studies, applying a safety factor of 100. The estimated exposure in the European population is well below the ADI, so it is considered safe.
In conclusion, E433 is a well-tolerated and safe additive under authorized conditions of use.
- Polysorbate 80
- Polyoxyethylene sorbitan monooleate
- POE (20) sorbitan monooleate
- Tween 80
Products in our Spanish database containing this additive
Examples found in ComerClaro Spanish product database
Product names and supermarket data may appear in Spanish.
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