Polysorbates
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Description
The food additive E432, known as polysorbates (specifically polysorbate 20, 40, 60, 65, and 80), is an emulsifier widely used in the food industry. They are esters of fatty acids (such as lauric, palmitic, stearic, or oleic acid) with polyethoxylated sorbitol. Their origin is synthetic, obtained by reacting sorbitol with ethylene oxide and subsequent esterification with fatty acids. Industrially, they are produced in chemical reactors under controlled conditions, yielding a viscous liquid or semi-solid yellowish substance, soluble in water and oils.
Polysorbates are non-ionic surfactants that reduce surface tension between immiscible phases, allowing the formation and stabilization of emulsions. Their main function is to prevent the separation of ingredients such as water and oil, improving texture, stability, and shelf life of products.
Historically, they were approved in the European Union in the 1970s and their use is regulated by Regulation (EC) No 1333/2008. The European Food Safety Authority (EFSA) has re-evaluated their safety on several occasions, most recently in 2015, establishing an Acceptable Daily Intake (ADI) of 10 mg/kg body weight for polysorbate 80 and 25 mg/kg for polysorbates 20, 40, 60, and 65. The World Health Organization (WHO) has also evaluated them, confirming their safety at authorized doses.
Regarding the overall safety assessment, polysorbates are considered safe for the general population when consumed within established limits. On labeling, they must appear as 'polysorbates' or with their corresponding E number. Although some animal studies have suggested possible effects on the intestinal microbiota, EFSA concludes that there is no evidence of adverse effects in humans at current exposure levels.
Polysorbates (E432) are used in a wide variety of food categories as emulsifiers, stabilizers, and coating agents. According to Regulation EC 1333/2008, they are authorized in fine bakery products (such as cakes and buns) up to 3 g/kg; in ice creams and dairy desserts up to 1 g/kg; in non-alcoholic beverages (including flavored milks) up to 0.5 g/kg; in sauces and dressings up to 5 g/kg; in confectionery products (chewing gum, candies) up to 1 g/kg; and in food supplements up to 5 g/kg.
In the Spanish market, they are found in ice creams from brands like Nestlé or Frigo, in cocoa creams like Nutella, in sauces like Hellmann's Mayonnaise, and in industrial bakery products like Donuts or Panrico. Comparatively, the US FDA also considers them GRAS (Generally Recognized as Safe) with similar limits, although in Japan their use is more restricted, allowed only in some products such as margarines and ice creams.
EFSA has established that the estimated dietary exposure is below the ADI for all population groups, even in high-level consumers.
Documented adverse effects of polysorbates are scarce and mainly based on animal studies at very high doses. In humans, no significant side effects have been reported at authorized use levels. Some in vitro and animal studies have suggested that polysorbates could alter intestinal permeability and microbiota, but EFSA concludes that these findings are not relevant to human exposure.
The proposed biological mechanism is that polysorbates can act as detergents, affecting cell membranes, but at dietary doses no adverse effects are observed. Sensitive populations such as people with inflammatory bowel disease could be more susceptible, but there is no conclusive evidence. No interactions with medications are known. EFSA and WHO have established ADIs that ensure a wide safety margin.
In conclusion, polysorbates are considered safe for human consumption at the amounts present in foods.
- Polysorbate 20
- Polysorbate 40
- Polysorbate 60
- Polysorbate 65
- Polysorbate 80
- Tween 20
- Tween 40
- Tween 60
- Tween 65
- Tween 80
- Polyoxyethylene sorbitan ester
- Polyoxyethylene sorbitan monooleate
- Polyoxyethylene sorbitan monolaurate
- Polyoxyethylene sorbitan monopalmitate
- Polyoxyethylene sorbitan monostearate
- Polyoxyethylene sorbitan tristearate
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