PRODUCTS

SORBITAN MONOLAURATE

Sorbitan monolaurate is a food emulsifier, solubiliser, crystallisation retarder, dough improver, antifoam agent, stabiliser Sorbitan laurate belongs to the family of Pentoses. These are monosaccharides in which the carbohydrate moiety contains five carbon atoms.

CAS NUMBER: 1338-39-2

SYNONYMS:

C18H34O6; Polyethylene glycol sorbitan monolaurate solution; Polyoxyethylenesorbitan monolaurate; Polyoxyethylene (20) sorbitan monolaurate; MFCD00165986; Sorbitan Monolaurate; Sorbitan monolaurate; Sorbitan laurate; Span(R) 20; Span® 20; CHEMBL2107561; SCHEMBL17307991; LWZFANDGMFTDAV-WYDSMHRWSA-N; MolPort-003-939-304; 6484AF; MFCD00005365; ST24026374; SR-01000883734; J-006440; SR-01000883734-1; 346.464 g/mol; LWZFANDGMFTDAV-WYDSMHRWSA-N; 16218599; C18H34O6; InChI=1S/C18H34O6/c1-2-3-4-5-6-7-8-9-10-11-16(21)23-13-15(20)18-17(22)14(19)12-24-18/h14-15,17-20,22H,2-13H2,1H3/t14-,15?,17+,18+/m0/s1

Sorbitan Monolaurate melts at 93 to 98 C depending on the form. Sorbitan Monolaurate is used as a a sweetening agent, food additive, toothpaste, tobacco, toiletries and in cosmetics. Sorbitan Monolaurate is used for vitamin-C fermentation. Sorbitan Monolaurate is used as a excipient and intravenous osmotic diuretic in pharmaceutical fields. Sorbitan Monolaurate is also used in the manufacture of polyethers for polyurethanes and surfactants. The term sorbitan describes the anhydride form of sorbitol, whose fatty acids are lipophilic whereas sorbitol body is hydrophilic. This bifunctionality in one molecule provides the basic properties useful in cleaners, detergents, polymer additives, and textile industry as emulsifiers, wetting agents, and viscosity modifiers. Sorbitan esters are rather lipophilic (or hydrophobic) surfactants exhibiting low HLB (Hydrophilic-Lipophilic Balance) values; having an affinity for, tending to combine with, or capable of dissolving in lipids (or water-insoluble).

Connect a suitable condenser to the flask, reflux the mixture for 1 to 2 h, and then transfer to an 800-ml beaker, rinsing the flask with about 100 ml of water and adding Sorbitan Monolaurate to the beaker. Heat on a steam bath to evaporate the alcohol, adding water occasionally to replace the alcohol, and evaporate until the odour of alcohol can no longer be detected. Adjust the final volume to about 250 ml with hot water. Neutralize the soap solution with dilute sulfuric acid (1 in 2), add 10% in excess, and heat, while stirring, until the fatty acid layer separates. Transfer the fatty acids to a 500-ml separator, wash with three or four 20- ml portions of hot water to remove polyols, and combine the washings with the original aqueous polyol layer from the saponification. Extract the combined aqueous layer with three 20-ml portions of petroleum ether, add the extracts to the fatty acid layer, evaporate to dryness in a tared dish, cool and weigh.

Neutralize the polyol solution with a 1 in 10 solution of potassium hydroxide to pH 7 using a suitable pH meter. Evaporate this solution to a moist residue, and separate the polyols from the salts by several extractions with hot alcohol. Evaporate the alcohol extracts on a steam bath to dryness in a tared dish, cool, and weigh. Avoid excessive drying and heating. Sorbitan monolaurate belongs to a group of substances called Sorbitane esters which are widely used as surface active substances and raw materials for cosmetics. The database for environmental effects, ecotoxicology and toxicology of Sorbitan monolaurate is extensive, allowing a robust evaluation of its hazard properties. Because of the lack of hazards and if the risk management recommendations as mentioned below are observed the substance can be handled safely. Sorbitan laurate is a common component in laundry products, cleaners, aerosol sprays, disinfectants, pest control sprays, polishes, water softeners, coatings, paints, thinners, paint removers and cosmetics.

The chemical structure of the Sorbitan laurate combines a good environmental profile, especially in terms of ready biodegradability and no harmful effects on aquatic life, with the structural features required for their manifold uses. Sorbitan laurate has to be considered as a substance that is omnipresent due to its numerous uses by the general public and its industrial uses. Sorbitan laurate contained in preparations like laundry products, cleaners, aerosol sprays, disinfectants, pest control sprays, polishes, water softeners, coatings, paints, thinners, paint removers and cosmetics. Sorbitol is a white, sweetish, hygroscopic, crystalline sugar alcohol of six-carbon. Sorbitan Monolaurate is found naturally in various berries and fruits. Or Sorbitan Monolaurate is prepared synthetically by high-pressure catalytic hydrogenation of glucose sugar derived from cornstarch.

Reaction products resulting from the esterification of Sorbitol with C8 - 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1; Sorbitan monolaurate (1338-39-2); Poly(oxyethylene) sorbitan monolaurate; Tween 20; Sorbitan Monolaurate; Sorbitan Monolaurate; Sorbitan Monododecanoate; SORBITAN; MONODODECANOATE; Sorbitan Monolaurate; POE (20) SORBITAN MONOLAURATE; Polyoxyethylene 20 Sorbitan Monolaurate; 3402132020; Sorbitan monododecanoate; Span 20; 346.47; L12099 Sorbitan monolaurate; 2-ethoxyethanol, ethanol and methanol; Sorbitan Monolaurate Liquid; Polyethylene glycol sorbitan monolaurate solution; Polyoxyethylenesorbitan monolaurate; Polyoxyethylene (20) sorbitan monolaurate; MFCD00165986; Sorbitan Monolaurate
Transfer about 25 g of the sample, accurately weighed, into a 500-ml round-bottom flask, add 250 ml of alcohol and 7.5 g of potassium hydroxide, and mix.

While, the ethoxylated sorbitan esters are hydrophilics exhibiting high HLB values; having an affinity for water; readily absorbing or dissolving in water. The type of fatty acid and the mole number of ethylene oxide provides diverse HLB values for proper applications. Nonionic surfactants are surface active agents which do not dissociate into ions in aqueous solutions, unlike anionic surfactants which have a negative charge and cationic surfactants which have a positive charge in aqueous solution. Nonionic surfactants are more widely used as detergents than ionic surfactants because anionic surfactants are insoluble in many hard water and cationic surfactants are considered to be poor cleaners. In addition to detergency, nonionic surfactants show excellent solvency, low foam properties and chemical stability. Sorbitan Monolaurate is thought that nonionic surfactants are mild on the skin even at high loadings and long-term exposure.

The hydrophilic group of nonionic surfactants is a polymerized alkene oxide (water soluble polyether with 10 to 100 units length typically). They are prepared by polymerization of ethylene oxide, propylene oxide, and butylene oxide in the same molecule. Depending on the ratio and order of oxide addition, together with the number of carbon atoms which vary the chemical and physical properties, nonionic surfactant is used as a wetting agent, a detergent, or an emulsifier. Nonionic surfactants include alcohol ethoxylates, alkylphenol ethoxylates, phenol ethoxylates, amide ethoxylates, glyceride ethoxylates (soya bean oil and caster oil ethoxylates), fatty acid ethoxylates, and fatty amine ethoxylates. Another commercially significant nonionic surfactants are the alkyl glycosides in which the hydrophilic groups are sugars (polysaccharides).

Sorbitan monolaurate is a mixture of esters formed from the fatty acid lauric acid and polyols derived from sorbitol, including sorbitan and isosorbide. As a food additive, Sorbitan Monolaurate is designated with the E number E493. The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. Sorbitan Monolaurate is currently authorised in the European Union and Sorbitan Monolaurate is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion.

The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters. Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use.
On 27 February 2019, the Panel on Additives an Products or Substances used in Animal Feed of the European Food Safety Authority (“Authority”), in its opinion on the safety of the product, could not conclude on the safety of Sorbitan monolaurate in all animal species, under the conditions of use as posed by the applicant. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. Sorbitan Monolaurate was suggested to check for the possibility to demonstrate the safety of the additive. The Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment and to allow a revision of Authority's opinion. The new data have been received on 2 April 2019.

IUPAC NAME:

(2R)-2-[(2R,3R,4S)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl dodecanoate; 1,4-anhydro-6-O-dodecanoyl-D-glucitol; 1,4-anhydro-6-O-dodecanoyl-D-glucitol; Dodecanoic acid [2-[(2R,3R,4S)-3,4-dihydroxy-2-tetrahydrofuranyl]-2-hydroxyethyl] ester; Esterification products of D-glucitol with C8 – C16 (even-numbered) and C18 unsaturated fatty acids; NONION LP-20R; SML; sorbitan laurate; Sorbitan laurate; sorbitan laurate; Sorbitan monododecanoate; Sorbitan MonoLaurate; Sorbitan MonoLaurate; Sorbitan Monolurate (SML)

TRADE NAME:

ALKAMULS S-20; Kosteran-L/1; Mosselman sorbitan monolaurate; RADIAMULS SORB 2125K, RADIASURF 7124; RADIASURF 7125; SABOFOG ML; SABONOL ML; SABOSORB ML; Sorbitan laurate; Sorbitan mono laurate; SPAK-20

OTHER NAME:

338-39-2; 507483-77-4; 507483-77-4; 53528-77-1; 53528-77-1; 55070-12-7; 55070-12-7; 76011-50-2; 76011-50-2; 8028-02-2; 8028-02-2

In view of the above, the Commission asks the Authority to deliver a new opinion on Sorbitan monolaurate as feed additive for all animal species based on the additional data submitted by the applicant. The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. Sorbitan Monolaurate is currently authorised in the European Union and Sorbitan Monolaurate is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate.

The lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion. The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters.

Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use. Regulation (EC) No 1831/20031 establishes rule governing the Community authorisation of additives for animal nutrition and, in particular, Article 9 defines the terms of the authorisation by the Commission. The applicant, Kemin Europa N.V, is seeking a Community authorisation of Sorbitan Monolaurate as feed additive to be used as an emulsified for all animal species (Table 1). On 27 February 2019, the Panel on Additives an Products or Substances used in Animal Feed of the European Food Safety Authority (“Authority”), in its opinion on the safety of the product, could not conclude on the safety of Sorbitan monolaurate in all animal species, under the conditions of use as posed by the applicant. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. Sorbitan Monolaurate was suggested to check for the possibility to demonstrate the safety of the additive.

The Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment and to allow a revision of Authority's opinion. The new data have been received on 2 April 2019. In view of the above, the Commission asks the Authority to deliver a new opinion on Sorbitan monolaurate as feed additive for all animal species based on the additional data submitted by the applicant. The re‐evaluation of the safety of sorbitan monolaurate for the environment is the object of the current risk assessment. Sorbitan Monolaurate is currently authorised as a technological additive, functional group (c) emulsifier, for all animal species.
monolaurate (E 493) is approved as a food additive (Commission Regulation (EU) No 1129/2011) in a wide range of commonly consumed foods (up to 10 g/kg), including dietary food supplements (quantum satis). Sorbitan stearate (E 491), sorbitan tristearate (E 492), sorbitan oleate (E 494), sorbitan palmitate (E 495) and sorbitol (E 420) are authorised as food additives in the EU.

The European Food Safety Authority (EFSA) FEEDAP Panel adopted, in 2019, an opinion on the safety and efficacy of sorbitan monolaurate as a feed additive for all animal species. In that opinion, owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. In the previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the environment due to lack of data and inherent uncertainties. The applicant has submitted additional information in support to the safety for the environment. Sorbitan monolaurate is intended to be used as emulsifier in feed materials and compound feed quantum satis but with a maximum content of 85 mg sorbitan monolaurate/kg complete feed.

In order to fulfil the lack of data identify in the previous assessment, the applicant submitted one study on degradation in marine water of sorbitan monolaurate,5 one on toxicity in marine sediment testing sorbitan monolaurate,6 and one on toxicity in marine water testing sorbitan monolaurate and sorbitan monooleate.7 In addition, a review of the literature on the safety of sorbitan esters for the environment was performed.8 The FEEDAP Panel assessed the new information available and considered in particular the following: (i) the outcome of the literature review on sorbitan esters, (ii) the available data on the Absorption, distribution, metabolism and excretion (ADME) of structurally related compounds (sorbitan esters), (ii) the study on the aerobic degradability of sorbitan monolaurate in seawater and (iii) the ecotoxicity data on marine crustaceans and in marine sediment organisms.

In performing the assessment, the FEEDAP Panel considered the additive as a mixture of different derivates of sorbitol and fatty acids, naturally present in plants/animal products used as food or feed. The toxicity of sorbitan monolaurate and sorbitan monooleate was tested in a study following good laboratory practices (GLPs) performed according to ISO 14669:1999 with the marine crustacean Acartia tonsa. Sorbitan monolaurate exhibited a 48‐h LC50 value of 452.8 mg/L and sorbitan monooleate a 48‐h LC50 > 10,000 mg/L.
Sorbitan monolaurate was tested in a sediment toxicity test with the intertidal amphipod Corophium volutator.13 According to the method, test duration was 10 days. Sorbitan monolaurate was characterised as poorly soluble and therefore was added to the test system via dried sediment. Well‐defined information was provided on the source of test species and sediment (Bay of Suckquoy, Scotland), acclimation period (4 days) and test conditions. Tests were conducted (under controlled illumination and temperature) in 1 L capacity glass beakers each containing 2 cm depth of amended sediment and 850 mL of overlying seawater. Three replicates were prepared for each test concentration; controls were replicated five times. In total, 60 organisms were exposed per concentration of the test item and 100 for control. The target wet weight nominal concentrations ranged from 10 to 10,000 mg/kg (10, 100, 320, 1,000, 10,000).

The validity criteria were fulfilled. Based on the obtained results, sorbitan monolaurate exhibited a 10‐day LC50 value of 1,141 mg/kg (dry weight) to the marine amphipod Corophium volutator in the sediment phase. The ecotoxicity of sorbitan monolaurate to marine sediment organisms is very low as well as to marine water species. The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. Sorbitan Monolaurate is currently authorised in the European Union and Sorbitan Monolaurate is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment.

The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion. The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters. Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use.
Sorbitan monolaurate (Span 20) is a mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible lauric acid. Sorbitan Monolaurate is an excipient. Sorbitan laurate is a non-ionic surfactant that is widely used as an emulsifier and stabilizer in pharmaceutical formulations, food and cosmetic industries. As a food additive, Sorbitan Monolaurate is designated with the E number E493. Span 20 finds application in topical preparations. Sorbitan Monolaurate is soluble in many fatty compositions and solvents and dispersible in water, dilute acids and alkalis. Recommended topical usage levels of 0.5-5%.

The physicochemical characteristics of the test substance (log Pow 1.23 -3.86), the molecular mass and the poor water solubility for Sorbitan monolaurate, ethoxylated are suggestive of low absorption from the gastro-intestinal tract subsequent to oral ingestion.From the acute oral toxicity studies, LD50 values exceeding 30000 mg/kg bw were found for Polysorbate 20 and 21. The only clinical sign observed in these studies was diarrhea. In the subchronic and chronic studies, diarrhea was also observed going along with an enlargement of the caecum that was observed at gross pathology. However, since effects on intestinal organs were observed at histopathology, an indication for systemic availability of the test substance or metabolites after a oral ingestion is given. After oral ingestion, Sorbitan fatty acid esters will undergo stepwise chemical changes in the gastro-intestinal fluids as a result of enzymatic hydrolysis.

The hydrolysis of Sorbitan fatty acid esters occurs within a maximum of 48h for mono-, di- and tri-ester but decreases with the number of esterified fatty acid so that no hydrolysis of hexa-ester occurs (Krantz 1951, Mattson and Nolen 1972, Treon 1967, Wick and Joseph 1953).The physico-chemical characteristics of the cleavage products (e.g. physical form, water solubility, molecular weight, log Pow, vapour pressure, etc.) will be different from those of the parent substance before absorption into the blood takes place, and hence the predictions based upon the physico-chemical characteristics of the parent substance do no longer apply (ECHA, 2008). However, for all cleavage products, Sorbitan Monolaurate is anticipated that they will be absorbed in the gastro-intestinal tract.

Highly lipophilic fatty acid will be absorbed by micelullar solubilisation (Ramirez et al., 2001), whereas the D-glucitol, being a highly water-soluble substance, will dissolve into the gastrointestinal fluids and slowly be absorbed with a subsequent metabolism in the liver (Senti 1986, Touster 1975).For the ethoxylated residues Sorbitan Monolaurate was previously shown that small proportions can be recovered as 14CO2 in the exhaled air but also in the faeces. With regard to the latter, the proportions increased with longer ethoxylate length (HERA 2009). Overall, a systemic bioavailability of Sorbitan monolaurate, ethoxylated and/or its metabolites is considered likely after oral ingestion. Molecular weight and N-octanol/water partition coefficient in combination with the low water solubility of the compound argue for not favouring dermal absorption. According to Dermwin v2.0 QSAR prediction dermal absorption of the test substance was also predicted to be low (see section 7.1.2.).

One dermal acute toxicity study (with a reliability of 4) revealed a LD50 of >3000 mg/kg bw in guinea pigs without any clinical signs or effects seen at gross pathology and histopathology. Neither the substance is irritating to the rabbit skin/eye nor causes sensitisation. Because no signs of systemic toxicity were seen in the skin/eye irritation studies, Sorbitan Monolaurate is unclear if the lack of general toxicity is due to low or no dermal absorption or due to the low toxicity of the test substance. Sorbitan Monolaurate can however be conjectured that the dermal absorption is propably not high. Overall, the calculated very low dermal absorption potential, water insolubility, the high molecular weight and the fact that the substance is not irritating to skin and eyes implies that dermal uptake of Sorbitan monolaurate, ethoxylated is considered as very limited in humans. Distribution within the body through the circulatory system depends on the molecular weight, the lipophilic character and water solubility of a substance. In general, the smaller the molecule, the wider is the distribution. If the molecule is lipophilic, Sorbitan Monolaurate is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues (ECHA, 2008).

Sorbitan fatty acid esters acids will undergo chemical changes as a result of enzymatic hydrolysis, leading to the cleavage products D-glucitol and fatty acids. D-glucitol, a small (MW 182.2 g/mol), polar water-soluble substance (log Pow -2.2), will be distributed in aqueous fluids by diffusion through aqueous channels and pores and oxidized by L-iditol dehydrogenase to fructose which is subsequently metabolized by the fructose metabolic pathway (Touster 1975). The fatty acids are also distributed in the organism and can be taken up by different tissues. They can be stored as triglycerides in adipose tissue depots or they can be incorporated into cell membranes (Masoro 1977). At the same time, fatty acids are also required as a source of energy and undergo beta-oxidisation. Thus, stored fatty acids underlie a continuous turnover as they are permanently metabolized and excreted. Bioaccumulation of fatty acids only takes place, if their intake exceeds the caloric requirements of the organism. An ethoxylated residue might also occur which most likely remains intact and might be excreted via bile into the small intestine as such (HERA 2009).

Experimental data obtained in the repeated dose toxicity studies showed abnormalities in kidney, spleen, testes and ovaries at gross pathology as well as microscopic observations of alterations in kidney, testes, lymphoid tissue, liver, and coronary tissues.Assumably, the test substance and/or their metabolites may at least reach the intestinal organs but probably not crosses the placental barrier, since there were no effects on litters observed in the available prenatal study. The test substance is a Sorbitan fatty acid ester.Esters are known to hydrolyse into carboxylic acids and alcohols by esterases (Fukami and Yokoi, 2012).Therefore Sorbitan Monolaurate is expected that the test substance hydrolyses to D-glucitol and the respective fatty acids under physiological conditions. Depending on the route of exposure, esterase-catalysed hydrolysis takes place at different places in the organism.

After oral ingestion, Sorbitan fatty acid esters will undergo chemical changes already in the gastro-intestinal fluids as a result of enzymatic hydrolysis.In contrast, substances which are absorbed through the pulmonary alveolar membrane or through the skin enter the systemic circulation directly before entering the liver where hydrolysis will basically take place. The first cleavage product, the fatty acid, is stepwise degraded by beta-oxidation based on enzymatic removal of C2 units in the matrix of the mitochondria in most vertebrate tissues.The C2 units are cleaved as acyl-CoA, the entry molecule for the citric acid cycle. For the complete catabolism of unsaturated fatty acids such as oleic acid, an additional isomerization reaction step is required. The alpha- and omega-oxidation, alternative pathways for oxidation, can be found in the liver and the brain, respectively (CIR, 1987).

For the second cleavage product D-glucitol Sorbitan Monolaurate was found, that Sorbitan Monolaurate is relatively slowly absorbed from the gastro-intestinal tract compared with glucose and that Sorbitan Monolaurate can be metabolized by the intestinal microflora (Senti 1986). Once absorbed, D-glucitol is primarily metabolized in the liver.The first step involves oxidation by L-iditol dehydrogenase to fructose which is metabolized by the fructose metabolic pathway (Touster 1975).D-glucitol does not enter tissues other than the liver and does not directly influence the metabolism of endogenous D-glucitol in other tissues. The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. Sorbitan Monolaurate is currently authorised in the European Union and Sorbitan Monolaurate is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate.
Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion.

Their appearance may vary from an amber-colored oily, viscous liquid, to a light cream color, to tan beads or flakes or a hard, waxy solid with a slight odor They are also used as surfactants or emulsifying agents in the preparation of emulsions, creams, and ointments for pharmaceutical and cosmetic use. Sorbitan use in asthma inhalers has been implicated in causing secondary bronchospasms in children. Sorbitan Monolaurate , also known as sorbitan laurate, is a mix of esters from the fatty acid lauric acid used as a food additive emulsifier to keep water and oils mixed. Ungraded products supplied by Spectrum are indicative of a grade suitable for general industrial use or research purposes and typically are not suitable for human consumption or therapeutic use. The FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use.

The term sorbitan describes the anhydride form of sorbitol, whose fatty acids are lipophilic whereas sorbitol body is hydrophilic. This bifunctionality in one molecule provides the basic properties useful in cleaners, detergents, polymer additives, and textile industry as emulsifiers, wetting agents, and viscosity modifiers. Sorbitan esters are rather lipophilic (or hydrophobic) surfactants exhibiting low HLB (Hydrophilic-Lipophilic Balance) values; having an affinity for, tending to combine with, or capable of dissolving in lipids (or water-insoluble). While, the ethoxylated sorbitan esters are hydrophilics exhibiting high HLB values; having an affinity for water; readily absorbing or dissolving in water. The type of fatty acid and the mole number of ethylene oxide provides diverse HLB values for proper applications.

Nonionic surfactants are surface active agents which do not dissociate into ions in aqueous solutions, unlike anionic surfactants which have a negative charge and cationic surfactants which have a positive charge in aqueous solution. Nonionic surfactants are more widely used as detergents than ionic surfactants because anionic surfactants are insoluble in many hard water and cationic surfactants are considered to be poor cleaners. In addition to detergency, nonionic surfactants show excellent solvency, low foam properties and chemical stability. Sorbitan Monolaurate is thought that nonionic surfactants are mild on the skin even at high loadings and long-term exposure. The hydrophilic group of nonionic surfactants is a polymerized alkene oxide (water soluble polyether with 10 to 100 units length typically). They are prepared by polymerization of ethylene oxide, propylene oxide, and butylene oxide in the same molecule.
Sorbitan monolaurate is a mixture of esters formed from the fatty acid lauric acid and polyols derived from sorbitol, including sorbitan and isosorbide. As a food additive, Sorbitan Monolaurate is designated with the E number E493.