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Sorbitan monopalmitate (SMP) is a food additive, permitted by the EU. It is entry E495 in the E number list of permitted food additives. It is also known under the trade name Span 40.
Span 40 is used in skin care, hair care and decorative cosmetics. It is also used as an effector in compositions capable of facilitating penetration across a biological barrier. Inactive ingredient of some medications it improves transdermal delivery of drugs and is a potential carrier for topical drug delivery.
The Panel noted that after oral administration sorbitan monostearate can be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol and excreted via urine or exhaled as CO2 or excreted intact in the faeces. The Panel considered that sorbitan esters did not raise concern for genotoxicity. Based on the no observed adverse effect level (NOAEL) of 2,600 mg sorbitan monostearate/kg bw per day, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491–495) singly or in combination.