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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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- Regulations originating from the EU
- 2012 No. 231
- ANNEX
- E 1521 POLYETHYLENE GLYCOL
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E 1521 POLYETHYLENE GLYCOL
| 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 | (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140) |
| Average molecular weight | 380 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 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 |
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