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Commission Directive 2008/84/EC (repealed)Dangos y teitl llawn

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) (Codified version) (repealed)

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E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)

SynonymsPolysorbate 60
Polyoxyethylene (20) sorbitan monostearate
DefinitionA mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
AssayContent not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
DescriptionA lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour
Identification
A. Solubility
Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
B. Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
WaterNot more than 3 % (Karl Fischer method)
Acid valueNot more than 2
Saponification valueNot less than 45 and not more than 55
Hydroxyl valueNot less than 81 and not more than 96
1,4-dioxaneNot more than 5 mg/kg
Ethylene oxideNot more than 0,2 mg/kg
Ethylene glycols (mono- and di-)Not more than 0,25 %
ArsenicNot more than 3 mg/kg
LeadNot more than 5 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg

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