TY - JOUR AU - Whelan, Kevin AB - Abstract Food additive intakes have increased with the increase in “ultra-processed” food consumption. Food additive emulsifiers have received particular research attention in recent years due to preliminary evidence of adverse gastrointestinal and metabolic health effects. In this review, the use of emulsifiers as food additives is discussed, and the current estimations of exposure to, and safety of, emulsifiers are critically assessed. Food additive emulsifier research is complicated by heterogeneity in additives considered to be emulsifiers and labelling of them on foods globally. Major limitations exist in estimating food additive emulsifier exposure, relating predominantly to a lack of available food occurrence and concentration data. Development of brand-specific food additive emulsifier databases are crucial to accurately estimating emulsifier exposure. Current research on the health effects of food additive emulsifiers are limited to in vitro and murine studies and small, acute studies in humans, and future research should focus on controlled human trials of longer duration. emulsifier, exposure, food additive, inflammatory bowel disease, legislation, safety INTRODUCTION The practice of adding substances to foods such as flavors, preservatives, and emulsifiers to enhance their appearance, taste, texture, and shelf life has occurred for hundreds of years. Intake of food additives has increased in recent decades, with the growing demand for convenient products with longer shelf life giving rise to the global increase in the consumption of ultra-processed foods.1 Recently, food additive emulsifiers have received particular attention on the basis of preliminary research suggesting they may be implicated in the pathogenesis of inflammatory bowel disease and metabolic syndrome.2–4 In this review, the use of emulsifiers as food additives is discussed and the current estimations of exposure to emulsifiers are critically assessed. FOOD ADDITIVE LEGISLATION Regulations regarding food additive use were first reported as early as the 1930s.5 The European Union (EU) Regulation No 1333/2008 defines food additives as “substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose.”6 Food additive legislation, definitions, and labelling are governed by several international regulatory bodies, some of which are described in Box 1. Different legislative bodies and organizations use varying definitions of food additive classes. Food additives are broadly categorized, by the EU, into “colors,” “sweeteners,” and “additives other than colors and sweeteners.”6 The Codex Alimentarius, a collection of international food standards advised upon by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (JECFA), categorizes food additives into functional classes (including emulsifiers and emulsifying salts) and technological purposes, which may be numerous for each functional class.7 The UK Food Standards Agency has developed unique functional groupings of food additives, including “emulsifiers,” “stabilizers,” and “gelling agents and thickeners.”8 The US Food and Drug Administration (FDA) refers to emulsifying agents as “emulsifiers or emulsifier salt” and Food Standards Australia and New Zealand (FSANZ) outlines technological functions of food additives but does not assign these functions to specific approved additives. Codex Alimentarius proposed the International Numbering System (INS) with the aim of producing a globally harmonized numbering system for food additives.7 This initiative, to some extent, has circumvented food labels needing to use the varying and often lengthy molecule names that may be confusing for consumers. In many countries, manufacturers now have the choice of including just the INS number on food ingredient labels instead of the emulsifier name. Currently, the INS list includes additives numbered 100–1522, but it is open and subject to the inclusion of new additives. In the EU, the letter “E” is prefixed to the INS numbers and additives are labelled as such on packaging (so-called E numbers). This INS has not been adopted by the US FDA but is used by FSANZ without the “E” prefix. food additive emulsifiers predominantly span INS numbers 400–495, although some fall outside of these numbers, such as lecithins (E322). EMULSIONS AND THE NEED FOR FOOD ADDITIVE EMULSIFIERS An emulsion is a heterogeneous suspension created when microscopic droplets of 1 immiscible liquid are dispersed in another immiscible liquid.9,10 To create an emulsion (in the absence of a food additive emulsifier) a physical force must be applied so the oil and water phases are agitated to encourage dispersion—for example, whisking oil and water vigorously. Once formed, emulsions are characterized by the spatial distribution of the oil and aqueous (water) phase. The dispersed liquid is described as the dispersion phase, and the other liquid is described as the continuous phase. There are 4 types of emulsions, as displayed in Figure 1A. An oil-in-water emulsion describes the dispersion of fat droplets in a water continuous phase, such as milk or mayonnaise. In contrast, a water-in-oil emulsion is formed when the continuous phase is fat and the dispersion phase is water, such as butter and vinaigrettes.11,12 Finally, there are 2 types of multilayer emulsions. A water-oil-water emulsion describes a water continuous phase and an oil-dispersed phase, but the oil also contains another water phase in its core, whereas an oil-water-oil emulsion describes an oil continuous phase with a water-dispersed phase containing an oil core. These multilayer emulsions are created by processing the liquids to produce microscopic particle sizes, with the benefit of improved stability. Figure 1 Open in new tabDownload slide Formation of an emulsion after physical homogenization. (A) Four different types of emulsion can be formed. (B) In the absence of a food additive emulsifier, an emulsion can be unstable and disperse by creaming, sedimentation, flocculation, coalescence, or separation. Figure 1 Open in new tabDownload slide Formation of an emulsion after physical homogenization. (A) Four different types of emulsion can be formed. (B) In the absence of a food additive emulsifier, an emulsion can be unstable and disperse by creaming, sedimentation, flocculation, coalescence, or separation. Once created, emulsions are unstable and readily revert to their separate phases. For example, over time, a mayonnaise can separate to leave oil at the top and vinegar at the bottom. As shown in Figure 1B, emulsions may cream, sediment, flocculate, coalesce, or separate.13 For example, droplets with lower densities may rise to the top of the emulsion (creaming) or droplets with higher density can fall to the bottom via gravitational forces (sedimentation). Two or more dispersed droplets may aggregate to form clusters, but the droplets maintain their individual integrity (flocculation), or the droplets can form larger, single droplets (coalescence, also known as Ostwald ripening). Finally, an emulsion can return to its constituent phases (separation). To prevent emulsions from returning to their distinct phases in a food product, food additive emulsifiers are frequently used to promote emulsion stability. Food additive emulsifiers are distinct from detergents. Both have surface-active properties that encourage droplet dispersion. However, detergent molecules are used for their cleaning properties in cosmetic, pharmaceutical, and cleaning preparations and are not added to foods.9 Food additive emulsifiers: structure and function Food additive emulsifiers are defined by Codex Alimentarius as additives that form or maintain a uniform emulsion of 2 or more phases in a food.7 Food additive emulsifiers have both hydrophilic and hydrophobic moieties and thus reduce interfacial tension between the oil and water phases, preventing suspended droplets within the emulsion from undergoing the processes shown in Figure 1B. There are numerous types of food additive emulsifiers, with varying chemical structures. The general structure of an amphiphilic emulsifier is shown in Figure 2. Figure 2 Open in new tabDownload slide The structure and action of a single amphiphilic emulsifying agent. The emulsifier molecules position along the interfacial layer, with hydrophilic heads facing the aqueous phase and hydrophobic tails facing the oil phase, thus establishing and maintaining the stability of the emulsion. Figure 2 Open in new tabDownload slide The structure and action of a single amphiphilic emulsifying agent. The emulsifier molecules position along the interfacial layer, with hydrophilic heads facing the aqueous phase and hydrophobic tails facing the oil phase, thus establishing and maintaining the stability of the emulsion. There are no universally recognized categories of emulsifier types or structure; however, some have broadly categorized emulsifiers into 3 classes: (1) low-molecular-weight emulsifiers (or small-molecule surfactants), (2) amphiphilic biopolymers, and (3) solid or colloidal particles.13 Low-molecular-weight emulsifiers consist of a hydrophilic head and hydrophobic tail, as shown in Figure 2, which may be nonionic or charged, and include the synthetic mono- and diglycerides, sucrose esters and sorbitan esters, polysorbates, or naturally derived phospholipids (eg, lecithins). Amphiphilic biopolymers comprise mostly proteins and polysaccharides. Proteins (eg, casein and whey) are generally amphiphilic and have emulsifying and foaming properties. Meanwhile, polysaccharides, such as gum arabic, pectins, xanthan gum, and guar gum, have thickening properties and may have nonpolar lipid or protein moieties that facilitate emulsification.14 Thickening agents stabilize emulsions by increasing viscosity, which limits the movement, and, therefore, separation, of emulsion droplets. Whether nonsurface-active amphiphilic biopolymers can be considered emulsifying agents is debated. Some amphiphilic biopolymers, such as methylcellulose and hydroxypropylmethylcellulose, have emulsifying properties, but due to their greater molecular weight, they may perform more poorly than low-molecular-weight emulsifiers.14 Some polysaccharides (eg, xanthan gum and guar gum) were believed to promote emulsification because they were contaminated with protein that facilitates adsorption to the oil-water interface.15 However, after purification of certain gums to eliminate contaminating proteins, the emulsifying capability remains, suggesting the emulsifying properties of some polysaccharides are independent of protein contamination.16 Finally, pickering emulsions are formed when solid or colloidal particles, such as starch and soy protein, adsorb at the O/W interface instead of traditional surfactant emulsifiers.17 These may produce a more stable emulsion due to reduced coalescence. A number of food additive emulsifiers have multiple technological functions. For example, carboxymethylcellulose (E466) may also behave as a stabilizer, thickener, firming agent, gelling agent, coating agent, glazing agent, or humectant.7 Multiple food additive emulsifiers are often used synergistically in 1 product to increase the stability of an emulsion.18 Food additives classified as emulsifiers There are discrepancies between different regulatory bodies and between different countries regarding which food additives are classified as emulsifiers (Table 1). Codex Alimentarius lists 261 additives under the functional class “emulsifier” or “emulsifying salt.”7 In contrast, the FSA lists only 63 additives as emulsifiers, stabilizers, gelling agents, and thickeners permitted in the EU,8 because many additives listed by Codex are not approved for use in the EU. Meanwhile, the FDA lists 171 approved additives as “emulsifiers or emulsifying salts,” and FSANZ does not provide a list of additives according to possible functional classes or technological purposes. As seen in Table 1, individual additives may be classed as emulsifiers by only certain regulatory bodies. For example, triphosphates (E451) are considered emulsifiers according to Codex but not JECFA. These discrepancies create difficulties in translating emulsifier research internationally and, therefore, the definition of what constitutes a low-emulsifier diet would likely differ by country. Table 1 Additives classed as emulsifiers according to regulatory bodies governing the use of food additives internationally and in the European Union, the United Kingdom, and United States Food additive emulsifier . INS number . Classified as a food additive emulsifier by the following regulatory bodies . JECFA . Codex . FSA (UK) . FDA (US) . Lecithin E322 ✓ ✓ ✓ ✓ Sodium lactate E325 ✓ ✓ Potassium lactate E326 ✓ Sodium citrates E331 ✓ ✓ Sodium tartrate E335 ✓ ✓ Sodium potassium tartrate E337 ✓ ✓ Sodium phosphates E339(i-iii) ✓ ✓ ✓ Potassium phosphates E340(i-iii) ✓ Tricalcium phosphate E341(iii) ✓ Metatartaric acid E353 ✓ Alginic acid E400 ✓ ✓ ✓ ✓ Sodium alginate E401 ✓ ✓ ✓ ✓ Potassium alginate E402 ✓ ✓ ✓ ✓ Ammonium alginate E403 ✓ ✓ ✓ ✓ Calcium alginate E404 ✓ ✓ ✓ Propylene glycol alginate E405 ✓ ✓ ✓ ✓ Sodium, calcium alginate E404 ✓ Agar E406 ✓ ✓ ✓ ✓ Carrageenan E407 ✓ ✓ ✓ ✓ Processed Euchema seaweed E407a ✓ ✓ ✓ Baker’s yeast glycan E408 ✓ Arabinogalactan E409 ✓ Carob bean gum E410 ✓ ✓ ✓ ✓ Oat gum E411 ✓ Guar gum E412 ✓ ✓ ✓ ✓ Tragacanth gum E413 ✓ ✓ ✓ Gum arabic E414 ✓ ✓ ✓ ✓ Xanthan gum E415 ✓ ✓ ✓ ✓ Karaya gum E416 ✓ ✓ ✓ ✓ Tara gum E417 ✓ Gellan gum E418 ✓ Gum ghatti E419 ✓ Octenyl succinic acid modified gum arabic E423 ✓ ✓ ✓ Konjac flour E425 ✓ ✓ ✓ Soybean hemicellulose E426 ✓ ✓ ✓ Cassia gum E427 ✓ ✓ ✓ Gelatine E428 ✓ Peptones E429 ✓ Polyoxyethylene (8) stearate E430 ✓ Polyoxyethylene (40) stearate E431 ✓ ✓ Polyoxyethylene (20) sorbitan monolaurate (polysorbate 20) E432 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monooleate (polysorbate 80) E433 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monopalmitate (polysorbate 40) E434 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monostearate (polysorbate 60) E435 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan tristearate (polysorbate 65) E436 ✓ ✓ ✓ ✓ Pectins E440 ✓ ✓ ✓ Superglycerinated hydrogenated rapeseed oil E441 ✓ Ammonium salts of phosphatidic acid E442 ✓ ✓ ✓ Brominated vegetable oils E443 ✓ Sucrose acetate isobutyrate E444 ✓ ✓ Glycerol esters of rosin E445 ✓ ✓ ✓ Succistearin E446 ✓ ✓ Diphosphates E450(i-viii) ✓ ✓ Triphosphates E451(i-iii) ✓ Polyphosphates E452(i-vi) ✓ ✓ Celluloses E460(i-ii) ✓ ✓ ✓ Methyl cellulose E461 ✓ ✓ ✓ ✓ Ethyl cellulose E462 ✓ ✓ Hydroxypropyl cellulose E463 ✓ ✓ ✓ ✓ Hydroxypropyl methyl cellulose E464 ✓ ✓ ✓ Methyl ethyl cellulose E465 ✓ ✓ ✓ Sodium carboxymethyl cellulose E466 ✓ ✓ ✓ ✓ Ethyl hydroxyethyl cellulose E467 ✓ ✓ Cross-linked sodium carboxymethylcellulose E468 ✓ ✓ Sodium carboxymethyl cellulose enzymatically hydrolyzed E469 ✓ ✓ Salts of fatty acids, with base of Ca, Mg, K, Na, Al, NH3 E470(i-iii) ✓ ✓ ✓ ✓ Mono- and diglycerides of fatty acids E471 ✓ ✓ ✓ ✓ Acetic and fatty acid esters of glycerol E472a ✓ ✓ ✓ Lactic and fatty acid esters of glycerol E472b ✓ ✓ ✓ Citric and fatty acid esters of glycerol E472c ✓ ✓ ✓ Tartaric acid esters of mono- and diglycerides of fatty acids E472d ✓ ✓ ✓ Diacetyltartaric and fatty acid esters of glycerol E472e ✓ ✓ ✓ Succinylated monoglycerides E472g ✓ ✓ ✓ Sucrose esters of fatty acids E473 ✓ ✓ ✓ Sucrose oligoesters, type I and type II E473a ✓ ✓ ✓ Sucroglycerides E474 ✓ ✓ ✓ Polyglycerol esters of fatty acids E475 ✓ ✓ ✓ ✓ Polyglycerol esters of interesterified ricinoleic acid E476 ✓ ✓ ✓ Propylene glycol esters of fatty acids E477 ✓ ✓ ✓ Lactylated fatty acid esters of glycerol and propylene glycol E478 ✓ ✓ ✓ Thermally oxidized soybean oil interacted with mono- and diglycerides of fatty acids E479 ✓ ✓ ✓ ✓ Dioctyl sodium sulfosuccinate E480 ✓ ✓ Sodium lactylates E481(i–ii) ✓ ✓ ✓ Calcium lactylates E482(i–ii) ✓ ✓ ✓ Stearyl tartrate E483 ✓ Stearyl citrate E484 ✓ ✓ Sodium stearoyl fumarate E485 ✓ Calcium stearoyl fumarate E486 ✓ Sodium laurylsulfate E487 ✓ Ethoxylated mono- and diglycerides E488 ✓ Methyl glucoside–coconut oil ester E489 ✓ Sorbitan monostearate E491 ✓ ✓ ✓ Sorbitan tristearate E492 ✓ ✓ ✓ Sorbitan monolaurate E493 ✓ ✓ ✓ Sorbitan monooleate E494 ✓ ✓ ✓ Sorbitan monopalmitate E495 ✓ ✓ ✓ Sorbitan trioleate E496 Stigmasterol-rich plant sterols E499 Sodium carbonate E500 ✓ ✓ Aluminum sulfate E520 ✓ Sodium aluminum phosphates E541(i–ii) ✓ ✓ Bone phosphate E542 ✓ ✓ Silicon dioxide E551 ✓ Stearic acid E570 ✓ Glycerin E640 ✓ Polydimethylsiloxane E900a ✓ Beeswax E901 ✓ Candelilla wax E902 ✓ Maltitols E965(i–ii) ✓ Lactitol E966 ✓ Xylitol E967 ✓ Quillaia extracts E999(i–ii) ✓ ✓ Cholic acid E1000 ✓ ✓ ✓ Choline salts and esters E1001(i–vi) ✓ ✓ Invertase E1103 ✓ Polyvinylpyrrolidone E1201 ✓ Dextrins, roasted starch E1400 ✓ ✓ Acid-treated starch E1401 ✓ ✓ Alkaline-treated starch E1402 ✓ ✓ Bleached starch E1403 ✓ Oxidized starch E1404 ✓ ✓ Starches, enzyme treated E1405 ✓ ✓ Monostarch phosphate E1410 ✓ ✓ Distarch glycerol E1411 ✓ ✓ Distarch phosphate E1412 ✓ ✓ Phosphated distarch phosphate E1413 ✓ ✓ Acetylated distarch phosphate E1414 ✓ ✓ Starch acetate E1420 ✓ ✓ Acetylated distarch adipate E1422 ✓ ✓ Hydroxypropyl starch E1440 ✓ ✓ Hydroxypropyl distarch phosphate E1442 ✓ ✓ Starch sodium octenyl succinate E1450 ✓ ✓ Acetylated oxidized starch E1451 ✓ ✓ Castor oil E1503 ✓ ✓ Triethyl citrate E1505 ✓ Triacetin E1518 ✓ Ethyl alcohol E1510 ✓ Propylene glycol E1520 ✓ ✓ Polyethylene glycol E1521 ✓ Basil oil (Ocimum basilicum) 182.2 a ✓ Casein 182.9 a ✓ Cellulose acetate 175.3 a ✓ Enzymes, proteolytic No code ✓ Furcelleran, salts of and ammonium salt 172.66 a ✓ Glycerin synthetic 172.866 a ✓ Lard 182.7 a ✓ Monoglyceride citrate 176.17 a ✓ Monoglycerides, acetylated 172.828 a ✓ Potassium pectinate 184.1588 a ✓ Potassium permanganate 175.105 a ✓ Rapeseed oil (hydrogenated, low erucic acid, partially hydrogenated) 184.1555 a ✓ Soybean oil fatty acids, hydroxylated 173.34 a ✓ Soy protein, isolate 176.18 a ✓ Food additive emulsifier . INS number . Classified as a food additive emulsifier by the following regulatory bodies . JECFA . Codex . FSA (UK) . FDA (US) . Lecithin E322 ✓ ✓ ✓ ✓ Sodium lactate E325 ✓ ✓ Potassium lactate E326 ✓ Sodium citrates E331 ✓ ✓ Sodium tartrate E335 ✓ ✓ Sodium potassium tartrate E337 ✓ ✓ Sodium phosphates E339(i-iii) ✓ ✓ ✓ Potassium phosphates E340(i-iii) ✓ Tricalcium phosphate E341(iii) ✓ Metatartaric acid E353 ✓ Alginic acid E400 ✓ ✓ ✓ ✓ Sodium alginate E401 ✓ ✓ ✓ ✓ Potassium alginate E402 ✓ ✓ ✓ ✓ Ammonium alginate E403 ✓ ✓ ✓ ✓ Calcium alginate E404 ✓ ✓ ✓ Propylene glycol alginate E405 ✓ ✓ ✓ ✓ Sodium, calcium alginate E404 ✓ Agar E406 ✓ ✓ ✓ ✓ Carrageenan E407 ✓ ✓ ✓ ✓ Processed Euchema seaweed E407a ✓ ✓ ✓ Baker’s yeast glycan E408 ✓ Arabinogalactan E409 ✓ Carob bean gum E410 ✓ ✓ ✓ ✓ Oat gum E411 ✓ Guar gum E412 ✓ ✓ ✓ ✓ Tragacanth gum E413 ✓ ✓ ✓ Gum arabic E414 ✓ ✓ ✓ ✓ Xanthan gum E415 ✓ ✓ ✓ ✓ Karaya gum E416 ✓ ✓ ✓ ✓ Tara gum E417 ✓ Gellan gum E418 ✓ Gum ghatti E419 ✓ Octenyl succinic acid modified gum arabic E423 ✓ ✓ ✓ Konjac flour E425 ✓ ✓ ✓ Soybean hemicellulose E426 ✓ ✓ ✓ Cassia gum E427 ✓ ✓ ✓ Gelatine E428 ✓ Peptones E429 ✓ Polyoxyethylene (8) stearate E430 ✓ Polyoxyethylene (40) stearate E431 ✓ ✓ Polyoxyethylene (20) sorbitan monolaurate (polysorbate 20) E432 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monooleate (polysorbate 80) E433 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monopalmitate (polysorbate 40) E434 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monostearate (polysorbate 60) E435 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan tristearate (polysorbate 65) E436 ✓ ✓ ✓ ✓ Pectins E440 ✓ ✓ ✓ Superglycerinated hydrogenated rapeseed oil E441 ✓ Ammonium salts of phosphatidic acid E442 ✓ ✓ ✓ Brominated vegetable oils E443 ✓ Sucrose acetate isobutyrate E444 ✓ ✓ Glycerol esters of rosin E445 ✓ ✓ ✓ Succistearin E446 ✓ ✓ Diphosphates E450(i-viii) ✓ ✓ Triphosphates E451(i-iii) ✓ Polyphosphates E452(i-vi) ✓ ✓ Celluloses E460(i-ii) ✓ ✓ ✓ Methyl cellulose E461 ✓ ✓ ✓ ✓ Ethyl cellulose E462 ✓ ✓ Hydroxypropyl cellulose E463 ✓ ✓ ✓ ✓ Hydroxypropyl methyl cellulose E464 ✓ ✓ ✓ Methyl ethyl cellulose E465 ✓ ✓ ✓ Sodium carboxymethyl cellulose E466 ✓ ✓ ✓ ✓ Ethyl hydroxyethyl cellulose E467 ✓ ✓ Cross-linked sodium carboxymethylcellulose E468 ✓ ✓ Sodium carboxymethyl cellulose enzymatically hydrolyzed E469 ✓ ✓ Salts of fatty acids, with base of Ca, Mg, K, Na, Al, NH3 E470(i-iii) ✓ ✓ ✓ ✓ Mono- and diglycerides of fatty acids E471 ✓ ✓ ✓ ✓ Acetic and fatty acid esters of glycerol E472a ✓ ✓ ✓ Lactic and fatty acid esters of glycerol E472b ✓ ✓ ✓ Citric and fatty acid esters of glycerol E472c ✓ ✓ ✓ Tartaric acid esters of mono- and diglycerides of fatty acids E472d ✓ ✓ ✓ Diacetyltartaric and fatty acid esters of glycerol E472e ✓ ✓ ✓ Succinylated monoglycerides E472g ✓ ✓ ✓ Sucrose esters of fatty acids E473 ✓ ✓ ✓ Sucrose oligoesters, type I and type II E473a ✓ ✓ ✓ Sucroglycerides E474 ✓ ✓ ✓ Polyglycerol esters of fatty acids E475 ✓ ✓ ✓ ✓ Polyglycerol esters of interesterified ricinoleic acid E476 ✓ ✓ ✓ Propylene glycol esters of fatty acids E477 ✓ ✓ ✓ Lactylated fatty acid esters of glycerol and propylene glycol E478 ✓ ✓ ✓ Thermally oxidized soybean oil interacted with mono- and diglycerides of fatty acids E479 ✓ ✓ ✓ ✓ Dioctyl sodium sulfosuccinate E480 ✓ ✓ Sodium lactylates E481(i–ii) ✓ ✓ ✓ Calcium lactylates E482(i–ii) ✓ ✓ ✓ Stearyl tartrate E483 ✓ Stearyl citrate E484 ✓ ✓ Sodium stearoyl fumarate E485 ✓ Calcium stearoyl fumarate E486 ✓ Sodium laurylsulfate E487 ✓ Ethoxylated mono- and diglycerides E488 ✓ Methyl glucoside–coconut oil ester E489 ✓ Sorbitan monostearate E491 ✓ ✓ ✓ Sorbitan tristearate E492 ✓ ✓ ✓ Sorbitan monolaurate E493 ✓ ✓ ✓ Sorbitan monooleate E494 ✓ ✓ ✓ Sorbitan monopalmitate E495 ✓ ✓ ✓ Sorbitan trioleate E496 Stigmasterol-rich plant sterols E499 Sodium carbonate E500 ✓ ✓ Aluminum sulfate E520 ✓ Sodium aluminum phosphates E541(i–ii) ✓ ✓ Bone phosphate E542 ✓ ✓ Silicon dioxide E551 ✓ Stearic acid E570 ✓ Glycerin E640 ✓ Polydimethylsiloxane E900a ✓ Beeswax E901 ✓ Candelilla wax E902 ✓ Maltitols E965(i–ii) ✓ Lactitol E966 ✓ Xylitol E967 ✓ Quillaia extracts E999(i–ii) ✓ ✓ Cholic acid E1000 ✓ ✓ ✓ Choline salts and esters E1001(i–vi) ✓ ✓ Invertase E1103 ✓ Polyvinylpyrrolidone E1201 ✓ Dextrins, roasted starch E1400 ✓ ✓ Acid-treated starch E1401 ✓ ✓ Alkaline-treated starch E1402 ✓ ✓ Bleached starch E1403 ✓ Oxidized starch E1404 ✓ ✓ Starches, enzyme treated E1405 ✓ ✓ Monostarch phosphate E1410 ✓ ✓ Distarch glycerol E1411 ✓ ✓ Distarch phosphate E1412 ✓ ✓ Phosphated distarch phosphate E1413 ✓ ✓ Acetylated distarch phosphate E1414 ✓ ✓ Starch acetate E1420 ✓ ✓ Acetylated distarch adipate E1422 ✓ ✓ Hydroxypropyl starch E1440 ✓ ✓ Hydroxypropyl distarch phosphate E1442 ✓ ✓ Starch sodium octenyl succinate E1450 ✓ ✓ Acetylated oxidized starch E1451 ✓ ✓ Castor oil E1503 ✓ ✓ Triethyl citrate E1505 ✓ Triacetin E1518 ✓ Ethyl alcohol E1510 ✓ Propylene glycol E1520 ✓ ✓ Polyethylene glycol E1521 ✓ Basil oil (Ocimum basilicum) 182.2 a ✓ Casein 182.9 a ✓ Cellulose acetate 175.3 a ✓ Enzymes, proteolytic No code ✓ Furcelleran, salts of and ammonium salt 172.66 a ✓ Glycerin synthetic 172.866 a ✓ Lard 182.7 a ✓ Monoglyceride citrate 176.17 a ✓ Monoglycerides, acetylated 172.828 a ✓ Potassium pectinate 184.1588 a ✓ Potassium permanganate 175.105 a ✓ Rapeseed oil (hydrogenated, low erucic acid, partially hydrogenated) 184.1555 a ✓ Soybean oil fatty acids, hydroxylated 173.34 a ✓ Soy protein, isolate 176.18 a ✓ a Food and Drug Administration Chemical Abstract Service numbers. Abbreviations: Codex, Codex Alimentarius; FDA, US Food and Drug Administration; FSA, Food Standards Agency; INS, International Numbering System; JECFA, Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives; UK, United Kingdom; US, United States. Open in new tab Table 1 Additives classed as emulsifiers according to regulatory bodies governing the use of food additives internationally and in the European Union, the United Kingdom, and United States Food additive emulsifier . INS number . Classified as a food additive emulsifier by the following regulatory bodies . JECFA . Codex . FSA (UK) . FDA (US) . Lecithin E322 ✓ ✓ ✓ ✓ Sodium lactate E325 ✓ ✓ Potassium lactate E326 ✓ Sodium citrates E331 ✓ ✓ Sodium tartrate E335 ✓ ✓ Sodium potassium tartrate E337 ✓ ✓ Sodium phosphates E339(i-iii) ✓ ✓ ✓ Potassium phosphates E340(i-iii) ✓ Tricalcium phosphate E341(iii) ✓ Metatartaric acid E353 ✓ Alginic acid E400 ✓ ✓ ✓ ✓ Sodium alginate E401 ✓ ✓ ✓ ✓ Potassium alginate E402 ✓ ✓ ✓ ✓ Ammonium alginate E403 ✓ ✓ ✓ ✓ Calcium alginate E404 ✓ ✓ ✓ Propylene glycol alginate E405 ✓ ✓ ✓ ✓ Sodium, calcium alginate E404 ✓ Agar E406 ✓ ✓ ✓ ✓ Carrageenan E407 ✓ ✓ ✓ ✓ Processed Euchema seaweed E407a ✓ ✓ ✓ Baker’s yeast glycan E408 ✓ Arabinogalactan E409 ✓ Carob bean gum E410 ✓ ✓ ✓ ✓ Oat gum E411 ✓ Guar gum E412 ✓ ✓ ✓ ✓ Tragacanth gum E413 ✓ ✓ ✓ Gum arabic E414 ✓ ✓ ✓ ✓ Xanthan gum E415 ✓ ✓ ✓ ✓ Karaya gum E416 ✓ ✓ ✓ ✓ Tara gum E417 ✓ Gellan gum E418 ✓ Gum ghatti E419 ✓ Octenyl succinic acid modified gum arabic E423 ✓ ✓ ✓ Konjac flour E425 ✓ ✓ ✓ Soybean hemicellulose E426 ✓ ✓ ✓ Cassia gum E427 ✓ ✓ ✓ Gelatine E428 ✓ Peptones E429 ✓ Polyoxyethylene (8) stearate E430 ✓ Polyoxyethylene (40) stearate E431 ✓ ✓ Polyoxyethylene (20) sorbitan monolaurate (polysorbate 20) E432 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monooleate (polysorbate 80) E433 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monopalmitate (polysorbate 40) E434 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monostearate (polysorbate 60) E435 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan tristearate (polysorbate 65) E436 ✓ ✓ ✓ ✓ Pectins E440 ✓ ✓ ✓ Superglycerinated hydrogenated rapeseed oil E441 ✓ Ammonium salts of phosphatidic acid E442 ✓ ✓ ✓ Brominated vegetable oils E443 ✓ Sucrose acetate isobutyrate E444 ✓ ✓ Glycerol esters of rosin E445 ✓ ✓ ✓ Succistearin E446 ✓ ✓ Diphosphates E450(i-viii) ✓ ✓ Triphosphates E451(i-iii) ✓ Polyphosphates E452(i-vi) ✓ ✓ Celluloses E460(i-ii) ✓ ✓ ✓ Methyl cellulose E461 ✓ ✓ ✓ ✓ Ethyl cellulose E462 ✓ ✓ Hydroxypropyl cellulose E463 ✓ ✓ ✓ ✓ Hydroxypropyl methyl cellulose E464 ✓ ✓ ✓ Methyl ethyl cellulose E465 ✓ ✓ ✓ Sodium carboxymethyl cellulose E466 ✓ ✓ ✓ ✓ Ethyl hydroxyethyl cellulose E467 ✓ ✓ Cross-linked sodium carboxymethylcellulose E468 ✓ ✓ Sodium carboxymethyl cellulose enzymatically hydrolyzed E469 ✓ ✓ Salts of fatty acids, with base of Ca, Mg, K, Na, Al, NH3 E470(i-iii) ✓ ✓ ✓ ✓ Mono- and diglycerides of fatty acids E471 ✓ ✓ ✓ ✓ Acetic and fatty acid esters of glycerol E472a ✓ ✓ ✓ Lactic and fatty acid esters of glycerol E472b ✓ ✓ ✓ Citric and fatty acid esters of glycerol E472c ✓ ✓ ✓ Tartaric acid esters of mono- and diglycerides of fatty acids E472d ✓ ✓ ✓ Diacetyltartaric and fatty acid esters of glycerol E472e ✓ ✓ ✓ Succinylated monoglycerides E472g ✓ ✓ ✓ Sucrose esters of fatty acids E473 ✓ ✓ ✓ Sucrose oligoesters, type I and type II E473a ✓ ✓ ✓ Sucroglycerides E474 ✓ ✓ ✓ Polyglycerol esters of fatty acids E475 ✓ ✓ ✓ ✓ Polyglycerol esters of interesterified ricinoleic acid E476 ✓ ✓ ✓ Propylene glycol esters of fatty acids E477 ✓ ✓ ✓ Lactylated fatty acid esters of glycerol and propylene glycol E478 ✓ ✓ ✓ Thermally oxidized soybean oil interacted with mono- and diglycerides of fatty acids E479 ✓ ✓ ✓ ✓ Dioctyl sodium sulfosuccinate E480 ✓ ✓ Sodium lactylates E481(i–ii) ✓ ✓ ✓ Calcium lactylates E482(i–ii) ✓ ✓ ✓ Stearyl tartrate E483 ✓ Stearyl citrate E484 ✓ ✓ Sodium stearoyl fumarate E485 ✓ Calcium stearoyl fumarate E486 ✓ Sodium laurylsulfate E487 ✓ Ethoxylated mono- and diglycerides E488 ✓ Methyl glucoside–coconut oil ester E489 ✓ Sorbitan monostearate E491 ✓ ✓ ✓ Sorbitan tristearate E492 ✓ ✓ ✓ Sorbitan monolaurate E493 ✓ ✓ ✓ Sorbitan monooleate E494 ✓ ✓ ✓ Sorbitan monopalmitate E495 ✓ ✓ ✓ Sorbitan trioleate E496 Stigmasterol-rich plant sterols E499 Sodium carbonate E500 ✓ ✓ Aluminum sulfate E520 ✓ Sodium aluminum phosphates E541(i–ii) ✓ ✓ Bone phosphate E542 ✓ ✓ Silicon dioxide E551 ✓ Stearic acid E570 ✓ Glycerin E640 ✓ Polydimethylsiloxane E900a ✓ Beeswax E901 ✓ Candelilla wax E902 ✓ Maltitols E965(i–ii) ✓ Lactitol E966 ✓ Xylitol E967 ✓ Quillaia extracts E999(i–ii) ✓ ✓ Cholic acid E1000 ✓ ✓ ✓ Choline salts and esters E1001(i–vi) ✓ ✓ Invertase E1103 ✓ Polyvinylpyrrolidone E1201 ✓ Dextrins, roasted starch E1400 ✓ ✓ Acid-treated starch E1401 ✓ ✓ Alkaline-treated starch E1402 ✓ ✓ Bleached starch E1403 ✓ Oxidized starch E1404 ✓ ✓ Starches, enzyme treated E1405 ✓ ✓ Monostarch phosphate E1410 ✓ ✓ Distarch glycerol E1411 ✓ ✓ Distarch phosphate E1412 ✓ ✓ Phosphated distarch phosphate E1413 ✓ ✓ Acetylated distarch phosphate E1414 ✓ ✓ Starch acetate E1420 ✓ ✓ Acetylated distarch adipate E1422 ✓ ✓ Hydroxypropyl starch E1440 ✓ ✓ Hydroxypropyl distarch phosphate E1442 ✓ ✓ Starch sodium octenyl succinate E1450 ✓ ✓ Acetylated oxidized starch E1451 ✓ ✓ Castor oil E1503 ✓ ✓ Triethyl citrate E1505 ✓ Triacetin E1518 ✓ Ethyl alcohol E1510 ✓ Propylene glycol E1520 ✓ ✓ Polyethylene glycol E1521 ✓ Basil oil (Ocimum basilicum) 182.2 a ✓ Casein 182.9 a ✓ Cellulose acetate 175.3 a ✓ Enzymes, proteolytic No code ✓ Furcelleran, salts of and ammonium salt 172.66 a ✓ Glycerin synthetic 172.866 a ✓ Lard 182.7 a ✓ Monoglyceride citrate 176.17 a ✓ Monoglycerides, acetylated 172.828 a ✓ Potassium pectinate 184.1588 a ✓ Potassium permanganate 175.105 a ✓ Rapeseed oil (hydrogenated, low erucic acid, partially hydrogenated) 184.1555 a ✓ Soybean oil fatty acids, hydroxylated 173.34 a ✓ Soy protein, isolate 176.18 a ✓ Food additive emulsifier . INS number . Classified as a food additive emulsifier by the following regulatory bodies . JECFA . Codex . FSA (UK) . FDA (US) . Lecithin E322 ✓ ✓ ✓ ✓ Sodium lactate E325 ✓ ✓ Potassium lactate E326 ✓ Sodium citrates E331 ✓ ✓ Sodium tartrate E335 ✓ ✓ Sodium potassium tartrate E337 ✓ ✓ Sodium phosphates E339(i-iii) ✓ ✓ ✓ Potassium phosphates E340(i-iii) ✓ Tricalcium phosphate E341(iii) ✓ Metatartaric acid E353 ✓ Alginic acid E400 ✓ ✓ ✓ ✓ Sodium alginate E401 ✓ ✓ ✓ ✓ Potassium alginate E402 ✓ ✓ ✓ ✓ Ammonium alginate E403 ✓ ✓ ✓ ✓ Calcium alginate E404 ✓ ✓ ✓ Propylene glycol alginate E405 ✓ ✓ ✓ ✓ Sodium, calcium alginate E404 ✓ Agar E406 ✓ ✓ ✓ ✓ Carrageenan E407 ✓ ✓ ✓ ✓ Processed Euchema seaweed E407a ✓ ✓ ✓ Baker’s yeast glycan E408 ✓ Arabinogalactan E409 ✓ Carob bean gum E410 ✓ ✓ ✓ ✓ Oat gum E411 ✓ Guar gum E412 ✓ ✓ ✓ ✓ Tragacanth gum E413 ✓ ✓ ✓ Gum arabic E414 ✓ ✓ ✓ ✓ Xanthan gum E415 ✓ ✓ ✓ ✓ Karaya gum E416 ✓ ✓ ✓ ✓ Tara gum E417 ✓ Gellan gum E418 ✓ Gum ghatti E419 ✓ Octenyl succinic acid modified gum arabic E423 ✓ ✓ ✓ Konjac flour E425 ✓ ✓ ✓ Soybean hemicellulose E426 ✓ ✓ ✓ Cassia gum E427 ✓ ✓ ✓ Gelatine E428 ✓ Peptones E429 ✓ Polyoxyethylene (8) stearate E430 ✓ Polyoxyethylene (40) stearate E431 ✓ ✓ Polyoxyethylene (20) sorbitan monolaurate (polysorbate 20) E432 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monooleate (polysorbate 80) E433 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monopalmitate (polysorbate 40) E434 ✓ ✓ ✓ Polyoxyethylene (20) sorbitan monostearate (polysorbate 60) E435 ✓ ✓ ✓ ✓ Polyoxyethylene (20) sorbitan tristearate (polysorbate 65) E436 ✓ ✓ ✓ ✓ Pectins E440 ✓ ✓ ✓ Superglycerinated hydrogenated rapeseed oil E441 ✓ Ammonium salts of phosphatidic acid E442 ✓ ✓ ✓ Brominated vegetable oils E443 ✓ Sucrose acetate isobutyrate E444 ✓ ✓ Glycerol esters of rosin E445 ✓ ✓ ✓ Succistearin E446 ✓ ✓ Diphosphates E450(i-viii) ✓ ✓ Triphosphates E451(i-iii) ✓ Polyphosphates E452(i-vi) ✓ ✓ Celluloses E460(i-ii) ✓ ✓ ✓ Methyl cellulose E461 ✓ ✓ ✓ ✓ Ethyl cellulose E462 ✓ ✓ Hydroxypropyl cellulose E463 ✓ ✓ ✓ ✓ Hydroxypropyl methyl cellulose E464 ✓ ✓ ✓ Methyl ethyl cellulose E465 ✓ ✓ ✓ Sodium carboxymethyl cellulose E466 ✓ ✓ ✓ ✓ Ethyl hydroxyethyl cellulose E467 ✓ ✓ Cross-linked sodium carboxymethylcellulose E468 ✓ ✓ Sodium carboxymethyl cellulose enzymatically hydrolyzed E469 ✓ ✓ Salts of fatty acids, with base of Ca, Mg, K, Na, Al, NH3 E470(i-iii) ✓ ✓ ✓ ✓ Mono- and diglycerides of fatty acids E471 ✓ ✓ ✓ ✓ Acetic and fatty acid esters of glycerol E472a ✓ ✓ ✓ Lactic and fatty acid esters of glycerol E472b ✓ ✓ ✓ Citric and fatty acid esters of glycerol E472c ✓ ✓ ✓ Tartaric acid esters of mono- and diglycerides of fatty acids E472d ✓ ✓ ✓ Diacetyltartaric and fatty acid esters of glycerol E472e ✓ ✓ ✓ Succinylated monoglycerides E472g ✓ ✓ ✓ Sucrose esters of fatty acids E473 ✓ ✓ ✓ Sucrose oligoesters, type I and type II E473a ✓ ✓ ✓ Sucroglycerides E474 ✓ ✓ ✓ Polyglycerol esters of fatty acids E475 ✓ ✓ ✓ ✓ Polyglycerol esters of interesterified ricinoleic acid E476 ✓ ✓ ✓ Propylene glycol esters of fatty acids E477 ✓ ✓ ✓ Lactylated fatty acid esters of glycerol and propylene glycol E478 ✓ ✓ ✓ Thermally oxidized soybean oil interacted with mono- and diglycerides of fatty acids E479 ✓ ✓ ✓ ✓ Dioctyl sodium sulfosuccinate E480 ✓ ✓ Sodium lactylates E481(i–ii) ✓ ✓ ✓ Calcium lactylates E482(i–ii) ✓ ✓ ✓ Stearyl tartrate E483 ✓ Stearyl citrate E484 ✓ ✓ Sodium stearoyl fumarate E485 ✓ Calcium stearoyl fumarate E486 ✓ Sodium laurylsulfate E487 ✓ Ethoxylated mono- and diglycerides E488 ✓ Methyl glucoside–coconut oil ester E489 ✓ Sorbitan monostearate E491 ✓ ✓ ✓ Sorbitan tristearate E492 ✓ ✓ ✓ Sorbitan monolaurate E493 ✓ ✓ ✓ Sorbitan monooleate E494 ✓ ✓ ✓ Sorbitan monopalmitate E495 ✓ ✓ ✓ Sorbitan trioleate E496 Stigmasterol-rich plant sterols E499 Sodium carbonate E500 ✓ ✓ Aluminum sulfate E520 ✓ Sodium aluminum phosphates E541(i–ii) ✓ ✓ Bone phosphate E542 ✓ ✓ Silicon dioxide E551 ✓ Stearic acid E570 ✓ Glycerin E640 ✓ Polydimethylsiloxane E900a ✓ Beeswax E901 ✓ Candelilla wax E902 ✓ Maltitols E965(i–ii) ✓ Lactitol E966 ✓ Xylitol E967 ✓ Quillaia extracts E999(i–ii) ✓ ✓ Cholic acid E1000 ✓ ✓ ✓ Choline salts and esters E1001(i–vi) ✓ ✓ Invertase E1103 ✓ Polyvinylpyrrolidone E1201 ✓ Dextrins, roasted starch E1400 ✓ ✓ Acid-treated starch E1401 ✓ ✓ Alkaline-treated starch E1402 ✓ ✓ Bleached starch E1403 ✓ Oxidized starch E1404 ✓ ✓ Starches, enzyme treated E1405 ✓ ✓ Monostarch phosphate E1410 ✓ ✓ Distarch glycerol E1411 ✓ ✓ Distarch phosphate E1412 ✓ ✓ Phosphated distarch phosphate E1413 ✓ ✓ Acetylated distarch phosphate E1414 ✓ ✓ Starch acetate E1420 ✓ ✓ Acetylated distarch adipate E1422 ✓ ✓ Hydroxypropyl starch E1440 ✓ ✓ Hydroxypropyl distarch phosphate E1442 ✓ ✓ Starch sodium octenyl succinate E1450 ✓ ✓ Acetylated oxidized starch E1451 ✓ ✓ Castor oil E1503 ✓ ✓ Triethyl citrate E1505 ✓ Triacetin E1518 ✓ Ethyl alcohol E1510 ✓ Propylene glycol E1520 ✓ ✓ Polyethylene glycol E1521 ✓ Basil oil (Ocimum basilicum) 182.2 a ✓ Casein 182.9 a ✓ Cellulose acetate 175.3 a ✓ Enzymes, proteolytic No code ✓ Furcelleran, salts of and ammonium salt 172.66 a ✓ Glycerin synthetic 172.866 a ✓ Lard 182.7 a ✓ Monoglyceride citrate 176.17 a ✓ Monoglycerides, acetylated 172.828 a ✓ Potassium pectinate 184.1588 a ✓ Potassium permanganate 175.105 a ✓ Rapeseed oil (hydrogenated, low erucic acid, partially hydrogenated) 184.1555 a ✓ Soybean oil fatty acids, hydroxylated 173.34 a ✓ Soy protein, isolate 176.18 a ✓ a Food and Drug Administration Chemical Abstract Service numbers. Abbreviations: Codex, Codex Alimentarius; FDA, US Food and Drug Administration; FSA, Food Standards Agency; INS, International Numbering System; JECFA, Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives; UK, United Kingdom; US, United States. Open in new tab Food additive emulsifier labelling Labelling practices for emulsifiers, like other food additives, vary around the world. In the EU, and in common with other food additives, either the E-number or the name of the food additive emulsifier must be listed, preceded by the technological function (eg, emulsifier: E466 or emulsifier: carboxymethylcellulose).19 However, there are no regulations on the spelling or presentation of food additive emulsifier names, meaning there can be inconsistency in labelling. For example, there are more than 5 configurations of carboxymethylcellulose (eg, carboxymethylcellulose, carboxy methyl cellulose, carboxymethyl cellulose, carboxy methylcellulose, carboxy-methyl cellulose). The FDA mandates that all ingredients used in foods in the United States are listed by their common or usual name; however, in contrast with EU regulations, not all food additives are required to be listed by the intended technological function (eg, as an emulsifier).20 For foods in Australia and New Zealand, FSANZ requires that ingredients be listed by either the common name or a generic name. Food additives, including emulsifiers, must also be declared according to the most relevant food-additive class and, in contrast to EU regulations, must be followed by the prescribed name or INS number in brackets.21 Therefore, in Australia and New Zealand, there is greater consistency in the appearance of emulsifier names on food packaging. None of the aforementioned regulatory bodies requires that quantities of emulsifiers be listed on food labels. FOOD ADDITIVE EMULSIFIERS IN THE FOOD SUPPLY Emulsifiers are used in the production of foods to give a uniform consistency and pleasant mouth feel, and to improve taste and aesthetics. Commonly used food additive emulsifiers (E-number in parentheses) in the EU include lecithin (E322; in 14% of all food products in the food supply), mono- and diglycerides of fatty acids (E471; in 7% of foods), guar gum (E412; in 6% of foods), xanthan gum (E415; in 5% of foods), carrageenan (E407; in 4% of foods), and celluloses (eg, carboxymethylcellulose [E460-E469]) in 2% of foods.22–27Table 2 lists the most common food uses of these food additive emulsifiers in the EU, based on the Mintel Global New Products Database data presented in EFSA re-evaluations for these emulsifiers. Table 2 Range of classes of food additive emulsifiers and their most common food uses in the European Union, based on Mintel Global New Products Database food subcategories between 2011 and 201722–27 Emulsifier category (E-number) . All foods containing this additive emulsifier, No. (%) . Five food categories a most commonly containing this additive emulsifier (% of foods in category containing this emulsifier) . Lecithin (E322) 373 237 (14) Individually wrapped chocolate pieces (86) Chocolate count lines (sold by count) (85) Seasonal chocolate (84) Nonindividually wrapped chocolate (80) Chocolate spreads (80) Mono- and diglycerides of fatty acids (E471) 470 164 (7) Dairy-based ice cream and frozen yogurt (74) Margarine and other blended spreads (60) Cakes, pastries, and sweet goods (51) Frozen desserts (48) Sandwiches and wraps (43) Guar gum (E412) 411 735 (6) Dairy-based products (66) Soy-based products (62) Water-based frozen desserts (48) Sandwich fillers and spreads (39) Salad products (34) Xanthan gum (E415) 479 408 (5) Mayonnaise (46) Sandwich fillers and spreads (38) Salad products (36) Dressings and vinegar (30) Table sauces (28) Carrageenan (E407) 444 189 (4) Flavored milk (70) Iced coffee (67) Dairy-based ice cream and frozen desserts (41) Chilled desserts (39) Cream (39) Celluloses, including carboxymethylcellulose (E460–E469) 490 683 (2) Vitamin and dietary supplements (28) Meal replacements and other drinks (22) Water-based ice popsicles and sorbets (17) Meat substitutes (15) Flavored milk (15) Emulsifier category (E-number) . All foods containing this additive emulsifier, No. (%) . Five food categories a most commonly containing this additive emulsifier (% of foods in category containing this emulsifier) . Lecithin (E322) 373 237 (14) Individually wrapped chocolate pieces (86) Chocolate count lines (sold by count) (85) Seasonal chocolate (84) Nonindividually wrapped chocolate (80) Chocolate spreads (80) Mono- and diglycerides of fatty acids (E471) 470 164 (7) Dairy-based ice cream and frozen yogurt (74) Margarine and other blended spreads (60) Cakes, pastries, and sweet goods (51) Frozen desserts (48) Sandwiches and wraps (43) Guar gum (E412) 411 735 (6) Dairy-based products (66) Soy-based products (62) Water-based frozen desserts (48) Sandwich fillers and spreads (39) Salad products (34) Xanthan gum (E415) 479 408 (5) Mayonnaise (46) Sandwich fillers and spreads (38) Salad products (36) Dressings and vinegar (30) Table sauces (28) Carrageenan (E407) 444 189 (4) Flavored milk (70) Iced coffee (67) Dairy-based ice cream and frozen desserts (41) Chilled desserts (39) Cream (39) Celluloses, including carboxymethylcellulose (E460–E469) 490 683 (2) Vitamin and dietary supplements (28) Meal replacements and other drinks (22) Water-based ice popsicles and sorbets (17) Meat substitutes (15) Flavored milk (15) a According to Mintel food categorization. Open in new tab Table 2 Range of classes of food additive emulsifiers and their most common food uses in the European Union, based on Mintel Global New Products Database food subcategories between 2011 and 201722–27 Emulsifier category (E-number) . All foods containing this additive emulsifier, No. (%) . Five food categories a most commonly containing this additive emulsifier (% of foods in category containing this emulsifier) . Lecithin (E322) 373 237 (14) Individually wrapped chocolate pieces (86) Chocolate count lines (sold by count) (85) Seasonal chocolate (84) Nonindividually wrapped chocolate (80) Chocolate spreads (80) Mono- and diglycerides of fatty acids (E471) 470 164 (7) Dairy-based ice cream and frozen yogurt (74) Margarine and other blended spreads (60) Cakes, pastries, and sweet goods (51) Frozen desserts (48) Sandwiches and wraps (43) Guar gum (E412) 411 735 (6) Dairy-based products (66) Soy-based products (62) Water-based frozen desserts (48) Sandwich fillers and spreads (39) Salad products (34) Xanthan gum (E415) 479 408 (5) Mayonnaise (46) Sandwich fillers and spreads (38) Salad products (36) Dressings and vinegar (30) Table sauces (28) Carrageenan (E407) 444 189 (4) Flavored milk (70) Iced coffee (67) Dairy-based ice cream and frozen desserts (41) Chilled desserts (39) Cream (39) Celluloses, including carboxymethylcellulose (E460–E469) 490 683 (2) Vitamin and dietary supplements (28) Meal replacements and other drinks (22) Water-based ice popsicles and sorbets (17) Meat substitutes (15) Flavored milk (15) Emulsifier category (E-number) . All foods containing this additive emulsifier, No. (%) . Five food categories a most commonly containing this additive emulsifier (% of foods in category containing this emulsifier) . Lecithin (E322) 373 237 (14) Individually wrapped chocolate pieces (86) Chocolate count lines (sold by count) (85) Seasonal chocolate (84) Nonindividually wrapped chocolate (80) Chocolate spreads (80) Mono- and diglycerides of fatty acids (E471) 470 164 (7) Dairy-based ice cream and frozen yogurt (74) Margarine and other blended spreads (60) Cakes, pastries, and sweet goods (51) Frozen desserts (48) Sandwiches and wraps (43) Guar gum (E412) 411 735 (6) Dairy-based products (66) Soy-based products (62) Water-based frozen desserts (48) Sandwich fillers and spreads (39) Salad products (34) Xanthan gum (E415) 479 408 (5) Mayonnaise (46) Sandwich fillers and spreads (38) Salad products (36) Dressings and vinegar (30) Table sauces (28) Carrageenan (E407) 444 189 (4) Flavored milk (70) Iced coffee (67) Dairy-based ice cream and frozen desserts (41) Chilled desserts (39) Cream (39) Celluloses, including carboxymethylcellulose (E460–E469) 490 683 (2) Vitamin and dietary supplements (28) Meal replacements and other drinks (22) Water-based ice popsicles and sorbets (17) Meat substitutes (15) Flavored milk (15) a According to Mintel food categorization. Open in new tab As can be seen from Table 2, food additive emulsifiers are consistently found in many food products, including breads, other baked products, and chocolate and confectionary. During bread baking, yeast produces carbon dioxide that can stretch and weaken the elastic gluten network. Therefore, emulsifiers such as diacetyl tartaric acid (E472e) or sodium/calcium stearoyl-2-lactylate (E481, E471) are used to strengthen the dough. Although this process is not fully understood,28 it is thought that emulsifiers increase the number of small carbon dioxide bubbles incorporated into the dough, producing a stronger dough with increased volume and improved texture. Mono- and diglycerides of fatty acids (E471) may be used to overcome bread staling by creating emulsified complexes with amylose, ensuring a soft crumb structure with an extended shelf life.28 Chocolate is described as a “dry” emulsion consisting of a continuous cocoa-butter fat phase and hydrophilic sugar and lipophilic cocoa molecules in the dispersion phase.29 When used in the production of chocolate, food additive emulsifiers coat the sugar to allow flow into the continuous fat phase and give a more even distribution of the sugar and cocoa molecules. Emulsifiers enable manufacturers to modify texture by controlling the viscosity or flow of the chocolate, thus allowing molding and shaping of chocolate.30 Lecithin (E322) reduces the viscosity of chocolate almost 10 times greater than cocoa butter and thus reduces ingredient costs.31 Ice cream is a multiphase frozen food containing ice crystals, air, fat globules, and partially coalesced fat-globule clusters dispersed in an unfrozen phase of sugars, proteins, and stabilizers.32 Milk, 1 of the primary ingredients of ice cream, is a natural emulsion, because the fat droplets are coated in natural milk proteins that act as emulsifiers and prevent the fat globules interacting.33 However, these natural protein emulsifiers are not useful in ice cream production because the fat needs to coalesce to trap air. The use of emulsifiers in ice cream production is complex. They are added to reduce the stability of the milk emulsion via competition with the natural milk proteins. This allows the fat globules in the milk to become free and partially coalesce, trapping air during the whipping phase. This is particularly true for polysorbate 80.34 Some emulsifiers, such as lecithin, guar gum, and carrageenan, prevent larger ice crystals from forming in ice cream and thus improve sensory characteristics and mouthfeel.30,35 Some emulsifiers are found naturally within foods. For example, although most lecithin for commercial food additive emulsifier use is generated from soybean oil, lecithin is a phospholipid also found widely within foods such as eggs, liver, soybeans, peanuts, and wheat germ.36 Lecithins are present in animal and plant intracellular membranes; therefore, dietary intake of naturally occurring lecithins in food are estimated to be 14–71 mg/kg body weight per day, similar to the food additive emulsifier lecithins (E322).22 Pectins (E440) are also naturally present in fruits such as apples and pears, and EFSA has estimated intakes from natural sources are between 2 and 14 mg/kg body weight per day.37 It is as yet unknown whether an food additive emulsifier used as an additive has the same metabolic effects as the same emulsifier found naturally in whole foods. Regulation of food additive emulsifier exposure Food additive emulsifiers undergo safety assessments before approval for use in foods, using the same approaches as other food additives. The responsible bodies for such safety assessments include JECFA (international), EFSA (EU), FDA (United States), and FSANZ (Australia and New Zealand). Acceptable daily intakes (ADIs) are calculated by EFSA, FDA, and FSANZ for many approved food additive emulsifiers, representing the quantity of the emulsifier that can be consumed daily without presenting an appreciable risk to health. The ADI is calculated by using human epidemiological observations, toxicity testing in animals (including long-term toxicity and carcinogenicity studies) and in vitro mechanistic studies to perform hazard identification or characterization. These studies are used to derive a reference point, which is the highest dose of an additive causing no detectable adverse alterations in the organism under investigation.38 There are 2 methods through which the reference point can be established. Traditionally, the no observed adverse effect level (NOAEL) is used to determine the highest experimental dose at which no adverse effects are observed. Alternatively, the benchmark dose approach uses a dose-response curve to estimate the dose-response relationship for a particular adverse effect to establish a reference point. There are limitations associated with the use of NOAEL, notably that it depends on the appropriate selection of experimental doses and relies on expert judgment of the appropriate dose for the NOAEL. In contrast, the benchmark dose approach incorporates a formal assessment of data quality. The CI will be wide for poor data sets; thus, the resulting reference point will be a more conservative estimate.39 For this reason, JECFA and EFSA recommend the benchmark dose approach for setting the reference point for food additives. The ADI, expressed as milligrams per kilogram of body weight per day, is derived from the NOAEL or benchmark dose after the addition of an uncertainty factor, which usually entails dividing the NOAEL by 100 to account for possible differences in tolerance of additives between animals and humans.38 For example, the ADI of 75 mg/kg of body weight per day for carrageenan is based on a maximum dose (NOAEL) of 7500 mg/day being tolerated in animal studies.40 Acceptable daily intakes may be set for groups of additives with similar properties (eg, EFSA sets a collective ADI of 25 mg/kg body weight per day for the polysorbate derivatives [E432–436]),41 and for some additives, limited evidence of toxicity results in no set ADI (ADI not specified). Maximum permitted levels (MPLs) or maximum use levels (MULs) are set by regulatory bodies as the concentrations at which manufacturers are permitted to use an additive in foods as a way of ensuring the ADI is not exceeded. The MPL/MUL may vary according to the food. For example, the FDA permits agar to be used in baked goods at a concentration of 0.8%, but in confections and frostings at 2.0%.20 In addition to variation in the MPLs/MULs set by different regulatory bodies, there is variation in the additives permitted in different food categories. For example, although gum arabic is permitted in “cakes, brownies, pastries, biscuits, muffins and cookies” by the FDA, it is not permitted in “fine bakery wares” by the EU or in “biscuits, cakes and pastries” by FSANZ.6,20,42 This, again, highlights the inconsistencies between countries and, therefore, the challenges in defining a low-emulsifier diet in the research setting. Estimating food additive emulsifier exposure Regulatory bodies must estimate population food additive intakes, including emulsifier intakes, to establish whether exposure is likely to regularly exceed the ADI. Furthermore, estimating food additive emulsifier exposure is crucial in research, because population exposure is central to estimating the possible health effects of these additives. The assessment of food additive emulsifier exposure, like other food additives, generally combines food consumption data with food additive concentration data. In the EU, a tiered exposure assessment is performed, using more refined data as the tiers progress.43 The purpose of the tiered exposure assessment is to identify additives for which a more detailed exposure assessment is warranted, on the basis of perceived risk (ie, progressing to more refined tiers where required). The tiers used by EFSA are described in Table 3. Table 3 European Food Safety Authority food additive exposure assessment tiers, depicting the 3 tiers for measuring food consumption and food additive concentrations, to calculate food additive exposure Tier . Food consumption data . Additive concentrations in food . 1 Theoretical food consumption data (maximum theoretical food and fluid consumption) MPL/MUL for the additive 2 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) MPL/MULfor the additive 3 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) Actual use levels of the additive in foods (eg, industry-reported data) Tier . Food consumption data . Additive concentrations in food . 1 Theoretical food consumption data (maximum theoretical food and fluid consumption) MPL/MUL for the additive 2 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) MPL/MULfor the additive 3 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) Actual use levels of the additive in foods (eg, industry-reported data) Abbreviations: MPL/MUL, maximum permitted level/maximum use level; NDNS, National Diet and Nutrition Survey. Open in new tab Table 3 European Food Safety Authority food additive exposure assessment tiers, depicting the 3 tiers for measuring food consumption and food additive concentrations, to calculate food additive exposure Tier . Food consumption data . Additive concentrations in food . 1 Theoretical food consumption data (maximum theoretical food and fluid consumption) MPL/MUL for the additive 2 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) MPL/MULfor the additive 3 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) Actual use levels of the additive in foods (eg, industry-reported data) Tier . Food consumption data . Additive concentrations in food . 1 Theoretical food consumption data (maximum theoretical food and fluid consumption) MPL/MUL for the additive 2 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) MPL/MULfor the additive 3 Actual national food consumption data (eg, from national dietary surveys, such as NDNS in United Kingdom) Actual use levels of the additive in foods (eg, industry-reported data) Abbreviations: MPL/MUL, maximum permitted level/maximum use level; NDNS, National Diet and Nutrition Survey. Open in new tab Tier 1 is the most crude, likely significantly overestimating both food consumption and food additive concentrations. Tier 2 exposure assessment uses actual national food consumption data and still assumes the additive is present at the MPL/MUL in all permitted foods (and, therefore, still overestimates actual food additive concentrations and, therefore, food additive intake). Tier 3 represents a more accurate estimate because it uses both actual national food consumption data and actual industry-reported food additive concentrations, which may be below the MPL/MUL used in the earlier tiers. To carry out food additive safety re-evaluations, EFSA implements a tier 2 and 3 assessment, the latter using industry-reported information on food additive use. For example, as part of the polysorbate (E432-436; a group of food additive emulsifiers) safety re-evaluation, data on actual polysorbate concentrations for most food categories in which polysorbates are permitted was provided by industry associations, including the European Food Emulsifiers Manufacturers Association, Food Drink Europe, and the Association of the European Self-Medication Industry.41 The EFSA Comprehensive European Food Consumption Database has been populated with national dietary survey data from different EU member states to provide food consumption data for additive safety re-evaluations. Combining MPLs/MULs or polysorbate concentration data provided by industry with food consumption data, population mean and 95th percentile polysorbate intakes were calculated for different age groups for both tier 2 and 3 assessments in the different EU member states. Nonetheless, it is difficult to compare additive intakes between countries, given that different methodologies are used for national dietary surveys between countries. In the United States and in Australia and New Zealand, the FDA and FSANZ, respectively, use similar methods of food additive exposure assessment.44,45 Food consumption data are derived from national dietary surveys, including the US Department of Agriculture Continuing Survey of Food Intakes by Individuals, and the National Health and Nutrition Examination Survey, and the Australian National Nutrition Survey. FSANZ uses a tiered approach to food additive exposure assessments; however, in contrast to EFSA, 5 tiers are included. An additional model-diet technique exists for exposure assessment in cases where no food consumption data are available from national dietary surveys. Furthermore, probabilistic exposure assessments are used by both the FDA and FSANZ, using computer modelling to account for variations in food consumption and food additive concentrations between food brands, thus representing a more realistic and accurate exposure estimate. Several aspects of these approaches result in inaccuracy of food-additive exposure assessment. Using MPLs/MULs and even industry-reported additive use levels (EFSA, FDA, FSANZ) result in potentially overestimated additive intakes, because they assume that all foods within a broad category (eg, “edible ices” in EFSA exposure assessments) contain the permitted food additive of interest, which is unlikely to be the case. For example, although some edible ices contain carrageenan, many do not, thus assuming all products within this category contain carrageenan would overestimate intake. Furthermore, different manufacturers may use differing levels of food additives, which may not be reported in industry-reported use data and may lead to an over- or underestimation of additive exposure. The omission of certain food categories from exposure assessments, due to a lack of industry-reported use-level data in these categories, may underestimate additive exposure. Furthermore, the use of industry-reported additive use assumes the quantity of the additive used during manufacturing is equal to that remaining in food as consumed, which may not be the case, because some additives (eg, carrageenan) may be influenced by environmental and processing factors such as pH, other food components, and temperature.46 Finally, the estimates assume the consumer is exposed to an additive daily over a lifetime, which may not be the case, due to within-person variations in dietary intake. The lack of information on food labels regarding the quantity of food additives used in foods renders it difficult to accurately and quantitatively estimate food additive intakes from dietary intake records alone,19–21 unless MPLs/MULs are assumed. Furthermore, it is challenging to obtain product formulations from food industry because manufacturers consider this sensitive information and are not legally obliged to provide such data. Evidence for food additive emulsifier intake Research groups have investigated food additive emulsifier exposure using a variety of methods. The Flavorings, Additives, and Contact Materials Exposure Task aimed to introduce additional parameters into EFSA tier 2 and 3 exposure calculations, allowing a probabilistic exposure assessment accounting for variation in industry-reported food additive concentration values, in line with the FDA and FSANZ exposure assessments.47 This project investigated intakes of 31 additives, including 6 emulsifier groups, in 8 European countries. Table 4 lists the tier 2 emulsifier exposure assessments for children and adults in the United Kingdom, showing that some individuals may exceed the ADI for some emulsifiers. For example, in the tier 2 assessment, the ADI for polysorbate (E432-436) was exceeded in children across all 4 analyzed countries (United Kingdom, Italy, France, Ireland). Furthermore, the ADI for sucrose esters and sucroglyceride (E473-474) was exceeded by high-consumer adults (95th percentile) in the United Kingdom, Ireland, and France, and even mean intakes of stearoyl lactylates (E481–482) exceeded the ADI in young children (aged 1–4 years) in the United Kingdom and Ireland. In all analyzed countries, mean intakes of sorbitan monolaurate and monooleate (E493-494) exceeded the ADI in adults and children. However, tier 3 exposure assessment reduced the mean intakes of many emulsifiers to below the ADI, highlighting the importance of using actual additive use data. That said, even in the tier 3 assessment, intake of some emulsifiers (ie, polysorbates, stearoyl lactylates, and sorbitan monolaurate and monooleate) exceeded the ADI in people who consumed large amounts of foods containing these emulsifiers, where a probabilistic approach was used. This is in line with EFSA re-evaluations, which have demonstrated that exposures to certain emulsifiers exceed the ADI, depending on the tier (and, therefore, accuracy) of assessment. For example, the polysorbate (E432-436) re-evaluation revealed that the ADI of 25 mg/kg body weight per day was exceeded by high-consumer (95th percentile) toddlers, children, adults, and the elderly, based on the tier 3 brand-loyal scenario.41 The possibility of certain individuals exceeding the ADI for certain emulsifiers requires additional investigation, ideally using more comprehensive data on the occurrence and concentration of food additives in individual branded foods. Table 4 Studies assessing population exposure to date to a range of emulsifier groups in the United Kingdom and the United States Emulsifier group (E-number) . Vin et al., 201347 . Shah et al., 201748 . . Children 4–18 y (United Kingdom) . Adults 19–64 y (United Kingdom) . Adults (United States) b . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) . . Mean population intake . 97.5th percentile intake . Mean intake . 97.5th percentile intake . Mean population intake . 90th percentile intake . Lecithin (E322) – – – – 61 (NA c) 114 (NA c) Polysorbates (E432–436) 5.33 (53) 16.65 (166) 2.67 (27) 8.10 (81) 5 d (20) 9 d (36) Carboxymethylcellulose (E466) – – – – 24 (NA c) 53 (NA c) Mono- and diglycerides of fatty acids (E471) – – – – 75 (NA c) 148 (NA c) Sucrose esters and sucroglycerides (E473–474) 20.34 (51) 50.35 (126) 15.82 (40) 59.95 (150) 9 (30) 17 (57) Polyglycerol esters of fatty acids (E475) 10.43 (42) 28.72 (115) 4.80 (19) 14.85 (59) – – Polyglycerol polyricinoleate (E476) – – – – 1 (13) 3 (40) Stearoyl lactylates (E481–482) 9.24 (46) 27.47 (137) 9.24 (46) 27.47 (137) 7 (35) 13 (65) Sorbitan esters (E493–494) 15.98 (320) 43.39 (868) 7.14 (143) 19.17 (383) – – Emulsifier group (E-number) . Vin et al., 201347 . Shah et al., 201748 . . Children 4–18 y (United Kingdom) . Adults 19–64 y (United Kingdom) . Adults (United States) b . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) . . Mean population intake . 97.5th percentile intake . Mean intake . 97.5th percentile intake . Mean population intake . 90th percentile intake . Lecithin (E322) – – – – 61 (NA c) 114 (NA c) Polysorbates (E432–436) 5.33 (53) 16.65 (166) 2.67 (27) 8.10 (81) 5 d (20) 9 d (36) Carboxymethylcellulose (E466) – – – – 24 (NA c) 53 (NA c) Mono- and diglycerides of fatty acids (E471) – – – – 75 (NA c) 148 (NA c) Sucrose esters and sucroglycerides (E473–474) 20.34 (51) 50.35 (126) 15.82 (40) 59.95 (150) 9 (30) 17 (57) Polyglycerol esters of fatty acids (E475) 10.43 (42) 28.72 (115) 4.80 (19) 14.85 (59) – – Polyglycerol polyricinoleate (E476) – – – – 1 (13) 3 (40) Stearoyl lactylates (E481–482) 9.24 (46) 27.47 (137) 9.24 (46) 27.47 (137) 7 (35) 13 (65) Sorbitan esters (E493–494) 15.98 (320) 43.39 (868) 7.14 (143) 19.17 (383) – – Data show the mean intake of different emulsifier groups at different levels of population intake (mean population intake and percentile intake) presented as both the actual intake (mg/kg body weight per day) and as a percentage of the ADI (where available). a Tier 2 exposure assessment performed using National Diet and Nutrition Survey and European Food Safety Authority maximum permitted levels. b Exposure estimated using 10–14 day survey food-consumption data from the NPD group National Eating Trends Nutrient Intake Database. c Given status of no ADI specified by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives. d Polysorbate-80 analyzed only. Abbreviations: –, no data available; ADI, acceptable daily intake; BW, body weight. Open in new tab Table 4 Studies assessing population exposure to date to a range of emulsifier groups in the United Kingdom and the United States Emulsifier group (E-number) . Vin et al., 201347 . Shah et al., 201748 . . Children 4–18 y (United Kingdom) . Adults 19–64 y (United Kingdom) . Adults (United States) b . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) . . Mean population intake . 97.5th percentile intake . Mean intake . 97.5th percentile intake . Mean population intake . 90th percentile intake . Lecithin (E322) – – – – 61 (NA c) 114 (NA c) Polysorbates (E432–436) 5.33 (53) 16.65 (166) 2.67 (27) 8.10 (81) 5 d (20) 9 d (36) Carboxymethylcellulose (E466) – – – – 24 (NA c) 53 (NA c) Mono- and diglycerides of fatty acids (E471) – – – – 75 (NA c) 148 (NA c) Sucrose esters and sucroglycerides (E473–474) 20.34 (51) 50.35 (126) 15.82 (40) 59.95 (150) 9 (30) 17 (57) Polyglycerol esters of fatty acids (E475) 10.43 (42) 28.72 (115) 4.80 (19) 14.85 (59) – – Polyglycerol polyricinoleate (E476) – – – – 1 (13) 3 (40) Stearoyl lactylates (E481–482) 9.24 (46) 27.47 (137) 9.24 (46) 27.47 (137) 7 (35) 13 (65) Sorbitan esters (E493–494) 15.98 (320) 43.39 (868) 7.14 (143) 19.17 (383) – – Emulsifier group (E-number) . Vin et al., 201347 . Shah et al., 201748 . . Children 4–18 y (United Kingdom) . Adults 19–64 y (United Kingdom) . Adults (United States) b . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) a . Mean intake, mg/kg BW/d (% ADI) . . Mean population intake . 97.5th percentile intake . Mean intake . 97.5th percentile intake . Mean population intake . 90th percentile intake . Lecithin (E322) – – – – 61 (NA c) 114 (NA c) Polysorbates (E432–436) 5.33 (53) 16.65 (166) 2.67 (27) 8.10 (81) 5 d (20) 9 d (36) Carboxymethylcellulose (E466) – – – – 24 (NA c) 53 (NA c) Mono- and diglycerides of fatty acids (E471) – – – – 75 (NA c) 148 (NA c) Sucrose esters and sucroglycerides (E473–474) 20.34 (51) 50.35 (126) 15.82 (40) 59.95 (150) 9 (30) 17 (57) Polyglycerol esters of fatty acids (E475) 10.43 (42) 28.72 (115) 4.80 (19) 14.85 (59) – – Polyglycerol polyricinoleate (E476) – – – – 1 (13) 3 (40) Stearoyl lactylates (E481–482) 9.24 (46) 27.47 (137) 9.24 (46) 27.47 (137) 7 (35) 13 (65) Sorbitan esters (E493–494) 15.98 (320) 43.39 (868) 7.14 (143) 19.17 (383) – – Data show the mean intake of different emulsifier groups at different levels of population intake (mean population intake and percentile intake) presented as both the actual intake (mg/kg body weight per day) and as a percentage of the ADI (where available). a Tier 2 exposure assessment performed using National Diet and Nutrition Survey and European Food Safety Authority maximum permitted levels. b Exposure estimated using 10–14 day survey food-consumption data from the NPD group National Eating Trends Nutrient Intake Database. c Given status of no ADI specified by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives. d Polysorbate-80 analyzed only. Abbreviations: –, no data available; ADI, acceptable daily intake; BW, body weight. Open in new tab In separate analyses, intakes of 7 common emulsifiers (polysorbate 80, carboxymethylcellulose, lecithin, mono and diglycerides of fatty acids, stearoyl lactylates, sucrose esters, and polyglycerol polyricinoleate) have been estimated in the United States48; the findings are summarized in Table 4. Food consumption data were obtained from national dietary surveys (National Health and Nutrition Examination Survey and the NPD group National Eating Trends Nutrient Intake Database), and MPLs/MULs were used for food additive concentration data. Of the investigated emulsifiers, mean exposure to lecithin (55 mg/kg body weight per day) and mono- and diglycerides (80 mg/kg body weight per day) was greatest, whereas polysorbate 80 and carboxymethylcellulose exposure was lower (8 and 27 mg/kg body weight per d, respectively). Intakes of the other 3 investigated emulsifiers ranged from 2 to 9 mg/kg body weight per day. The mean or 90th percentile intakes did not exceed the ADI (as specified by JECFA) for any of the emulsifiers, although no ADI is specified for carboxymethylcellulose, lecithin, or mono- and diglycerides. Because the additives were assumed to be present at the MPLs/MULs in all permitted foods, this likely represents an overestimation of emulsifier intakes. Because intakes at the mean and 90th percentile did not exceed the ADIs, these findings indicate little concern regarding potentially excessive intakes of these 7 emulsifiers in the United States. However, 171 additives are considered emulsifiers in that country, and the intake of the majority of these has not been presented. To more accurately estimate food additive emulsifier intakes, extensive data are required on occurrence of emulsifiers in foods. Food ingredient databases that include data on emulsifier content are not widely available, although the Irish National Food Ingredient Database compiled food additive occurrence within packaged branded foods in the Irish food supply.49 This demonstrated that mono- and diglycerides of fatty acids and lecithin contributed most to emulsifier occurrence, which is in line with the aforementioned dietary intake findings in the United States.48 A similar assessment has been performed for food flavorings as part of the Flavorings, Additives, and Contact Materials Exposure Task project.50 Similar large-scale assessments of emulsifier occurrence are needed to estimate dietary intake more accurately with a lower risk of overestimating intakes. Limitations concerning food consumption data also need to be addressed when measuring food additive emulsifier intake. National dietary surveys do not collect food consumption information at the brand level, which is important due to variations in emulsifier content of similar products from different brands. For example, although some brands of bread contain mono- and diglycerides of fatty acids (E471), other brands do not, thus dietary exposure to E471 may vary significantly depending on the brand consumed. Therefore, to gain an accurate estimation of food additive emulsifier intakes, information on consumption of individual branded foods (for which data on additive concentrations would also need to be available) is crucial. An analysis of brand-level emulsifier intakes was performed in 20 patients in the United Kingdom with Crohn's disease using 7-day food diaries, although only a semiquantitative intake assessment was possible due to the absence of actual emulsifier concentrations in the reported food products.51 This showed that lecithins, mono- and diglycerides of fatty acids, pectins, diacetyl tartaric acid esters of mono- and diglycerides, and xanthan gum were most commonly consumed. This is in line with findings of previous emulsifier occurrence analyses52 and with EFSA safety re-evaluations. Finally, the presence of natural emulsifiers in foods (eg, lecithin in eggs), as discussed previously in this review, complicates exposure assessments because limited food composition data renders it difficult to estimate intake of these natural emulsifiers. Safety assessment of food additive emulsifiers Given the ubiquity of food additive emulsifiers in the food supply and the likelihood of intake increasing with increasing intake of ultra-processed food, it is essential that the safety of food additive emulsifiers continues to be assessed. Any emerging data on chemical and biological properties, toxicological effects and concentrations in foods require evaluation. Therefore, since 2009, the EFSA Panel on Food Additives and Flavorings (consisting of scientists with expertise in chemical risk assessment and safety assessment of food additives) has undertaken safety re-evaluations of food additives previously authorized for use before 2009,53 including emulsifiers. These evaluations use all available literature on each additive, including the original safety evaluation and any new data provided after open calls for data. The re-evaluations of emulsifiers are ongoing but have been completed for many commonly eaten emulsifiers, including lecithins (E322), mono- and diglycerides of fatty acids (E471), xanthan gum (E415), guar gum (E412), and carrageenan (E407). The FDA assesses safety of food additives, including emulsifiers, using a process that assesses the likely lifetime exposure of individuals to the additive and the level of consumption that is likely to be safe, based on toxicological studies.44 In Australia and New Zealand, FSANZ follows the Codex Alimentarius model for assessing the safety of food additives, which includes a hazard assessment and dietary exposure assessment. Many food additive emulsifiers appear to have limited toxicity. For example, because of a lack of adverse effects and no evidence of genotoxicity or carcinogenicity in animal studies even at the highest doses of many commonly used emulsifiers, including lecithins (E322), mono- and diglycerides of fatty acids (E471), xanthan gum (E415), and guar gum (E412), food additive emulsifiers continue to be assigned an ADI “not specified” by EFSA.22–25 Some emulsifiers, such as carrageenan (E407) and the polysorbates (E432-436), are assigned an ADI because of more evidence of adverse effects. In chronic toxicity studies, no adverse effects were identified in animal models after receiving maximum carrageenan doses of 7500 mg,26 and no concerns have been raised in terms of genotoxicity or carcinogenicity. However, degraded iota carrageenan has been associated with colitis and tumors in rats and monkeys, even at low doses. Given the lack of information on molecular weights of carrageenan used in toxicological studies, carrageenan has an ADI of 75 mg/kg body weight per day by EFSA,53 although JECFA has set an ADI not specified.54 Forestomach squamous hyperplasia, inflammation, and ulcers have been observed in mice after polysorbate-80 administration,55 with a NOAEL of 3750 mg, whereas the carcinogenicity study showed equivocal evidence for carcinogenic activity of polysorbate-80 with a NOAEL of 2500 mg. Therefore, the ADI of 25 mg/kg body weight per day was derived by dividing this value by an uncertainty factor of 100. It is important to note, however, that safety assessments within the EFSA re-evaluations are based predominantly on animal and in vitrostudies and limited acute studies in humans. More recently, a series of studies have raised concerns regarding the safety of certain emulsifiers and thickeners (namely, carrageenan, polysorbate 80, and carboxymethylcellulose), in particular in relation to their impact on the intestinal environment.3,4,56–61 A full review of the health implications of food additive emulsifiers is outside the remit of this review; however, some food additive emulsifiers modify the luminal and/or mucosal microbiome,3,4 increase intestinal permeability,56,57,60 and increase intestinal inflammation,3,4,58,59,61 all processes that are relevant to the development of colitis. However, these studies are not without limitations, including the majority being undertaken in vitro or in animal models. Experimental doses of emulsifiers given in animal models are often much higher than average exposure in humans. Therefore, additional human studies are urgently required to confirm the role of emulsifiers in gut inflammation. Indeed, the European Food Safety Authority’s Emerging Risks report, identified “food emulsifiers, the gut microbiome and long-term health effects” as requiring urgent research.62 FUTURE RESEARCH ON FOOD ADDITIVE EMULSIFIERS Numerous uncertainties exist regarding emulsifiers in foods, their exposure in the food supply, and their effects on health. A major consideration is the heterogeneity in types of food additive emulsifiers in the food supply. There are more than 100 possible food additive emulsifiers in the global food supply and their chemical structures and physiologic effects differ significantly. Toxicological studies for many of these were conducted in animals or were of limited duration in humans. Hence, establishing which emulsifiers are most likely to cause adverse health effects with chronic exposure (and in individuals exceeding the ADI) in humans requires more investigation through adequately powered randomized controlled trials. Numerous challenges have been discussed in this review regarding the estimation of exposure to food additive emulsifiers. Data on the occurrence and concentrations of emulsifiers within manufactured products are lacking; therefore, estimations of intake to date likely overestimated or underestimated emulsifier intake. Data on actual emulsifier occurrence and concentrations in branded foods, in the form of composition databases of manufactured foods, are needed to accurately assess population emulsifier exposure. This has been performed to a limited extent in France and the United States48–52; however, these surveys did not assess emulsifier concentrations in branded foods, and more extensive food databases are required to accurately establish chronic exposure and, therefore, potential adverse health effects of emulsifiers. This will require food industry collaboration to provide data on concentrations of emulsifiers in individual branded products. One method to assess emulsifier exposure would be to identify urinary, fecal, or circulating biomarkers for their consumption. To date, studies have examined the metabolism and excretion of emulsifiers using radiolabelling techniques, mainly in murine studies. For example, polysorbate 80 metabolism and excretion have been investigated through 14C-labelling of the sorbitan moiety, showing that 91% is excreted in feces.63 However, the fatty acid chain is likely hydrolyzed and absorbed, because the majority is exhaled in breath carbon dioxide in murine studies of polysorbate 20.41 Our current limited understanding of the absorption, metabolism, and excretion of many emulsifiers poses a challenge in identifying a biomarker for emulsifier consumption. Some emulsifiers, such as celluloses, xanthan gum, and guar gum, are unlikely to be absorbed intact but are fermented by certain colonic bacteria, producing metabolites such as short-chain fatty acids.24,25 It is unclear which compounds should be targeted as biomarkers for these emulsifiers and in which biological samples they should be quantified (ie, feces, urine, or blood). Studies investigating the adverse effects of emulsifiers on gastrointestinal disease and metabolic syndrome at doses feasible for chronic daily human exposure are currently limited to a selection of only 3 emulsifiers: carrageenan, polysorbate 80, and carboxymethylcellulose.3,4,64 The gastrointestinal, microbiome, and metabolic effects of chronic consumption of other emulsifying agents, of which there are in excess of 100 in the food supply worldwide, remain relatively unknown. Currently, 1 registered, ongoing trial is investigating the effects of soy lecithin on gut function, gut inflammation, and glucose metabolism in healthy individuals (ClinicalTrials.gov identifier NCT03842514) and 1 randomized placebo-controlled trial is investigating the effect of a low food-additive diet in Crohn disease (ClinicalTrials.gov identifier NCT04046913). Additional in vitro and animal studies at doses lower than those used in acute toxicity studies, and, importantly, in controlled human trials, are needed to establish the long-term safety of other emulsifiers. Consumers have mixed perceptions of food additives, with chemophobia referring to the fear of chemicals in food that is widespread among consumers.65 A qualitative study among 13 food experts indicated that consumer distrust of food additives (or E-numbers) relates to negative communication in the media and social media.66 The term clean label has been cited increasingly since the 1980s, referring to food labels with minimal additives listed,67 and manufacturers have increasingly sought to produce foods lower in food additives to meet consumer demand. Certain food additives, such as aspartame and monosodium glutamate, have particularly been associated with negative consumer opinions.68,69 Consumer perceptions of food additive emulsifiers specifically has not been studied to date, to our knowledge, but given emerging potential for adverse health effects, this is an important area for research through surveys and qualitative investigation. CONCLUSION Food additive emulsifiers are abundant in the food supply, with more than 100 emulsifying agents known to be added to foods globally. Emerging evidence suggests possible adverse effects of certain emulsifiers on gastrointestinal and metabolic health; however, evidence for such effects are currently limited to a handful of emulsifiers and the gastrointestinal and metabolic effects of chronic exposure to other common emulsifiers remain largely unknown. Research into the effects of food additive emulsifiers on health faces challenges associated with a relative lack of information on the occurrence and concentration of emulsifiers in manufactured foods, as well as heterogeneity in emulsifier labelling on foods, resulting in inaccurate estimations of emulsifier exposure and difficulty in implementing a low-emulsifier diet between countries. No biomarkers of emulsifier consumption are currently known but would aid in estimating emulsifier exposure and monitoring compliance in dietary intervention trials. Acknowledgments Author contributions. All authors contributed to the writing of the review and critically reviewed and approved the final version of this paper. All authors were involved in planning the scope, content, and design of the review. S.C. led on the writing of the manuscript and A.S., L.S., and K.W. contributed to the writing and review of the manuscript throughout. L.S. designed Figures 1 and 2. K.W. and M.R. reviewed and provided critical comment on the intellectual content of the manuscript. Funding. Authors are supported by a grant from The Leona M. and Harry B. Helmsley Charitable Trust. The funder had no role in the design, performance or approval of this review. Declaration of interests. K.W. is the co-inventor of a mobile phone application to assist patients follow dietary restrictions (FoodMaestro FODMAP app) and receives research funding from the Almond Board of California, Danone, and the International Dried Fruit and Nut Council. M.R. is the co-founder of a plant-based food brand (Bio&Me) and receives research funding from the Almond Board of California, Danone, and the International Fruit and Nut Council. All other authors had no conflicts of interest to report. References 1 Monteiro CA , Moubarac JC, Cannon G, et al. Ultra-processed products are becoming dominant in the global food system . Obes Rev. 2013 ; 14 : 21 – 28 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Roberts CL , Rushworth SL, Richman E, et al. Hypothesis: increased consumption of emulsifiers as an explanation for the rising incidence of Crohn’s disease . J Crohns Colitis . 2013 ; 7 : 338 – 341 . 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This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model) TI - Food additive emulsifiers: a review of their role in foods, legislation and classifications, presence in food supply, dietary exposure, and safety assessment JF - Nutrition Reviews DO - 10.1093/nutrit/nuaa038 DA - 2020-07-06 UR - https://www.deepdyve.com/lp/oxford-university-press/food-additive-emulsifiers-a-review-of-their-role-in-foods-legislation-WEWv9KBaQf SP - 1 EP - 1 VL - Advance Article IS - DP - DeepDyve ER -