Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives

Abstract

The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day (group ADI for polysorbates 20, 40, 60, 65 and 80) and the Scientific Committee on Food (SCF) derived a group ADI of 10 mg/kg bw/day. Small amounts of polyoxyethylene sorbitans are absorbed. Similar toxicokinetics would be expected for all polysorbates based on their similarities in structure and metabolic fate. The acute toxicity is very low. There is no concern regarding genotoxicity, carcinogenicity or developmental toxicity. From a limited number of studies, there is no indication of reproductive toxicity. The Panel considered the long-term carcinogenicity study in rats with a No Observed Adverse Effect Level (NOAEL) equivalent to 2 500 mg/kg bw/day -consistent with the NOAEL defined in subchronic studies -as the key study and allocated a group ADI of 25 mg/kg bw/day using an uncertainty factor of 100. The estimated exposure of toddlers at the highest level in non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day). The Panel is aware that for three food categories no reported uses have been obtained and that other dietary sources of exposure to polysorbates could not been considered in this opinion and therefore more data (usage and analytical data) are needed to decrease uncertainties in the refined exposure assessment scenario used. 20, 40, 60, 65 and 80 (SCF, 1985). The basis was a No Observed Effect Level (NOEL) equivalent to 1 460 mg/kg bw/day in the diet in the 90-day study in rats with polyoxyethylene sorbitan monostearate (polysorbate 60) (BIBRA, 1981; cited in SCF, 1985). A higher group ADI value of 0-25 mg/kg bw/day was allocated by the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA, 1974a, b).The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, additional literature that has become available since then and data available following a public call for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. Specifications for the polysorbates have been defined in Commission Regulation (EU) No 231/2012 and by JECFA (JECFA, 2006a).The Panel considered the evaluation of polysorbates (E 432-E 436) as a group in one opinion because of their similarities in structure and metabolic fate. These additives are hydrolysed to oxyethylene sorbitans and the relevant fatty acids, the latter being normal constituents of the diet. From the toxicological data as described in this opinion, there is ...

Dietary Emulsifiers Alter Composition and Activity of the Human Gut Microbiota in vitro, Irrespective of Chemical or Natural Emulsifier Origin

“…While CMC is resistant to breakdown by human digestive enzymes (Joint FAO/WHO Expert Committee on Food Additives, 1973), P80 and soy lecithin can be hydrolyzed by pancreatic lipases. For P80, only the polyethylene-sorbitan unit may reach the colon (Aguilar et al, 2015). Soy lecithin is mostly absorbed as lysolecithin and free fatty acids, but its detection in faces indicates that some fraction reaches the colon (Mortensen et al, 2017), where the choline and glycerol moieties are metabolized by the gut microbiota (Tang and Hazen, 2014).…”

“…P80 is a member of the polysorbates, a group of non-ionic surfactants with applications mainly in the food, cosmetics, and pharmaceutical industries (Nielsen et al, 2016;FMI, 2020). With an acceptable daily intake of 25 mg/kg BW/day (Aguilar et al, 2015), EFSA allows its use in products like sauces, soups, chewing gum, coconut milk, dairy products, and usually at maximal concentrations of 10-10,000 mg/kg, depending on the product (European Commision, 2011). Also the United States Food and Drug Administration (FDA) limits the use of P80 to 4-10,000 mg/ kg, depending on the product (FDA, 2019a).…”

Anti-vaccine movements – a form of social activity for health care, ignorance or diversion aimed at destabilizing the health situation? Part 1. Epidemiological safety. Vaccinations – pros and cons

“…The content of polysorbate 80 in vaccines is definitely small and a single dose of HPV vaccine contains only 50 micrograms of polysorbate 80, while the acceptable daily intake is 25 mg/kg body weight. (total of 20, 40, 60, 65 and 80 polysorbates) [47]. For example, the content of polysorbate 80 in ice cream reaches 0.5% (v /v) [29], which produces up to 170 mg of this compound in a typical ice cream cone [48].…”

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“…The FDA has granted PS80 the status of generally recognized as safe (GRAS), and both PSs are listed in its Inactive Ingredients Database [8]. Per the WHO, the accepted oral daily intake of PSs by adults is 25 mg/kg, compared with 10 mg/kg as suggested by the Scientific Committee on Food [9,10].…”