Polyoxyethylene 40 stearate
Score impact
0.00
points/product
Description
E431, known as polyoxyethylene 40 stearate (POE 40 stearate), is a food additive used as an emulsifier and stabilizer. It is obtained by reacting stearic acid (a saturated fatty acid of vegetable or animal origin) with ethylene oxide, forming a polyethylene glycol (PEG) ester with a chain of approximately 40 ethylene oxide units.
Industrially, the process involves esterification of stearic acid with PEG 40, followed by purification. It is a waxy solid, white or yellowish, soluble in water and ethanol, with a melting point between 45-55 °C. Its main function is to reduce surface tension between immiscible phases (water and oil), improving texture, stability, and shelf life of products.
It was approved as a food additive in the European Union in the 1970s, and its use is regulated by Regulation (EC) No 1333/2008. The European Food Safety Authority (EFSA) has re-evaluated its safety several times, most recently in 2018, establishing an Acceptable Daily Intake (ADI) of 25 mg/kg body weight per day. The World Health Organization (WHO) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) have also evaluated it, setting a similar ADI.
Overall, it is considered safe at authorized doses, although moderation in consumption of processed foods is recommended. On labels, it must appear as 'polyoxyethylene 40 stearate' or with its E number E431.
E431 is mainly used as an emulsifier and stabilizer in bakery and pastry products, such as breads, buns, cakes, and cookies, to improve texture and fluffiness. It is also used in confectionery, ice cream, emulsified sauces, and dairy drinks.
In the Spanish market, it is found in industrial sliced bread, packaged pastries, baking mixes, and some ice creams. According to Regulation (EC) No 1333/2008, maximum limits vary by category: in fine bakery wares up to 2,000 mg/kg, in common bread up to 1,000 mg/kg, in ice cream up to 1,000 mg/kg, and in emulsified sauces up to 5,000 mg/kg. In the United States, the FDA considers it GRAS (Generally Recognized as Safe) for similar uses, without specific limits, but with good manufacturing practices. In Japan, its use is allowed in certain processed foods with restrictions.
Compared to other emulsifiers like mono- and diglycerides (E471), E431 has a stronger emulsifying capacity but is used in smaller amounts.
Toxicological studies conducted by EFSA and JECFA have not identified significant adverse effects in humans at authorized doses. In animals, very high doses (above 250 mg/kg bw/day) have shown mild laxative effects and alterations in gut microbiota, but these levels are not relevant to human exposure.
The proposed biological mechanism is that PEG 40 stearate may be partially hydrolyzed in the intestine, releasing stearic acid and PEG, which are mainly excreted in feces. No carcinogenic, genotoxic, or teratogenic effects have been documented. Sensitive populations such as people with inflammatory bowel disease might experience digestive discomfort with very high consumption, but there is no conclusive evidence. No interactions with medications are known. EFSA concluded that estimated dietary exposure is below the ADI of 25 mg/kg bw/day, even in high-level consumers.
Therefore, it is considered safe under authorized conditions of use.
- Polyethylene glycol 40 stearate
- POE (40) stearate
- Polyoxyethylene (40) stearate
- PEG-40 stearate
- Polyethylene glycol ester of stearic acid
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