ArticleEFSA journal. European Food Safety Authority2015
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.
Article in EFSA journal. European Food Safety Authority, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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Who cites it
19 citing papers in PubMed.
- Trial
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- Antimicrobial Efficiency of Essential Oil and Microemulsion ofACS omega · 2026Article
- Factors Influencing Biofilm Formation ofFoods (Basel, Switzerland) · 2026Article
- Assessment of the feed additive consisting of coated granulated calcium iodate anhydrous for all animal species for the renewal of its authorisation (DOX-AL ITALIA SPA).EFSA journal. European Food Safety Authority · 2026Article
- Food Additives: Emerging Detrimental Roles on Gut Health.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2025Review
- Substitution of polysorbates by plant-based emulsifiers: impact on vitamin D bioavailability and gut health in mice.Communications biology · 2025Article
- Validation, measurement uncertainty, and determination of polysorbate-labeled foods distributed in Korea.Food science and biotechnology · 2024Article
- Emulsification and stabilisation technologies used for the inclusion of lipophilic functional ingredients in food systems.Heliyon · 2024Review
- Design of mobile and website health application devices for drug tolerability in hereditary fructose intolerance.Orphanet journal of rare diseases · 2024Article
- Emulsifiers in ultra-processed foods in the UK food supply.Public health nutrition · 2023Article
- Polysorbate 80 improves the adhesion and survival of yogurt starters with cholesterol uptake abilities.Saudi journal of biological sciences · 2022Article
- Food Emulsifiers and Metabolic Syndrome: The Role of the Gut Microbiota.Foods (Basel, Switzerland) · 2022Review
- Article
- Dietary Emulsifiers Directly Impact Adherent-Invasive E. coli Gene Expression to Drive Chronic Intestinal Inflammation.Cell reports · 2020Article
- Dietary Emulsifiers Alter Composition and Activity of the Human Gut MicrobiotaFrontiers in microbiology · 2020Article
- Pediatric Safety of Polysorbates in Drug Formulations.Children (Basel, Switzerland) · 2019Article
- Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209).EFSA journal. European Food Safety Authority · 2017Article
- 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.EFSA journal. European Food Safety Authority · 2015Article
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1 author.
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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.
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