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Commission Regulation (EU) No 231/2012Show full title

Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (Text with EEA relevance)

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E 1521 POLYETHYLENE GLYCOLU.K.

SynonymsPEG; Macrogol; Polyethylene oxide
DefinitionAddition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight.
Chemical namealpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)
Chemical formula(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140)
Average molecular weight380 to 9 000 Da
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 range

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
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 ashNot more than 0,2 %
1,4-DioxaneNot more than 10 mg/kg
F1...F1...
Ethylene glycol and diethylene glycolTotal not more than 0,25 % °w/w individually or in combination
LeadNot more than 1 mg/kg

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