Commission Directive 2008/84/EC (repealed)Show full title

[F1 E 1521 POLYETHYLENE GLYCOLS U.K.

Synonyms	PEG, Macrogol, Polyethylene oxide
Definition	Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight
Chemical name	alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)
Chemical formula	HOCH 2 - (CH 2 - O - CH 2 ) n - CH 2 OH
Average molecular weight	380 to 9 000 D
Assay	PEG 400: Not less than 95 % and not more than 105 % PEG 3000: Not less than 90 % and not more than 110 % PEG 3350: Not less than 90 % and not more than 110 % PEG 4000: Not less than 90 % and not more than 110 % PEG 6000: Not less than 90 % and not more than 110 % PEG 8000: Not less than 87,5 % and not more than 112,5 %
Description	PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance
Identification
Melting point	PEG 400: 4-8 °C PEG 3000: 50-56 °C PEG 3350: 53-57 °C PEG 4000: 53-59 °C PEG 6000: 55-61 °C PEG 8000: 55-62 °C
Viscosity	PEG 400: 105 to 130 mPa.s at 20 °C PEG 3000: 75 to 100 mPa.s at 20 °C PEG 3350: 83 to 120 mPa.s at 20 °C PEG 4000: 110 to 170 mPa.s at 20 °C PEG 6000: 200 to 270 mPa.s at 20 °C PEG 8000: 260 to 510 mPa.s at 20 °C For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water
Solubility	PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils
Purity
Acidity or alkalinity	Dissolve 5,0 g in 50 ml of carbon dioxide-free water and add 0,15 ml of bromothymol blue solution . The solution is yellow or green. Not more than 0,1 ml of 0,1 M sodium hydroxide is required to change the colour of the indicator to blue
Hydroxyl value	PEG 400: 264-300 PEG 3000: 34-42 PEG 3350: 30-38 PEG 4000: 25-32 PEG 6000: 16-22 PEG 8000: 12-16
Sulphated ash	Not more than 0,2 %
1,4-Dioxane	Not more than 10 mg/kg
Ethylene oxide	Not more than 0,2 mg/kg
Ethylene glycol and diethylene glycol	Total not more than 0,25 % w/w individually or in combination
Lead	Not more than 1 mg/kg]

Textual Amendments

F1 Substituted by Commission Directive 2010/67/EU of 20 October 2010 amending Directive 2008/84/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance).