LegalizeCommission 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
| Synonyms | Talcum |
| Definition | Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite. The product should be free of asbestos. |
| Einecs | 238-877-9 |
| Chemical name | Magnesium hydrogen metasilicate |
| Chemical formula | Mg3(Si4O10)(OH)2 |
| Molecular weight | 379,22 |
| Assay | |
| Description | Light, homogeneous, white or almost white powder, greasy to the touch |
| Identification | Identification |
| Infrared absorption spectrum | Characteristic peaks at 3 677 , 1 018 and 669 cm-1 |
| X-ray diffraction | Peaks at 9,34/4,66/3,12 Å |
| Solubility | Insoluble in water and ethanol |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (105 °C, 1 hour) |
| Acid soluble matter | Not more than 6 % |
| Water soluble matter | Not more than 0,2 % |
| Acid-soluble iron | Not detectable |
| Arsenic | Not more than 10 mg/kg |
| Lead | Not more than 2 mg/kg |
E 554 SODIUM ALUMINIUM SILICATE
| Synonyms | Sodium silicoaluminate; Sodium aluminosilicate; Aluminium sodium silicate |
| Definition | Definition |
| Einecs | |
| Chemical name | Sodium aluminium silicate |
| Chemical formula | |
| Molecular weight | |
| Assay | Content on the anhydrous basis: — as SiO2 not less than 66,0 % and not more than 88,0 % — as Al2O3 not less than 5,0 % and not more than 15,0 % |
| Description | Fine white amorphous powder or beads |
| Identification | Identification |
| Test for sodium | Passes test |
| Test for aluminium | Passes test |
| Test for silicate | Passes test |
| pH | Between 6,5 and 11,5 (5 % slurry) |
| Purity | Purity |
| Loss on drying | Not more than 8,0 % (105 °C, 2 hours) |
| Loss on ignition | Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 °C to constant weight) |
| Sodium | Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 555 POTASSIUM ALUMINIUM SILICATE
| Synonyms | Mica |
| Definition | Natural mica consists of mainly potassium aluminium silicate (muscovite) |
| Einecs | 310-127-6 |
| Chemical name | Potassium aluminium silicate |
| Chemical formula | KAl2AlSi3O102 |
| Molecular weight | 398 |
| Assay | Content not less than 98 % |
| Description | Light grey to white crystalline platelets or powder |
| Identification | Identification |
| Solubility | Insoluble in water, diluted acids and alkali and organic solvents |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (105 °C, 2 hours) |
| Antimony | Not more than 20 mg/kg |
| Zinc | Not more than 25 mg/kg |
| Barium | Not more than 25 mg/kg |
| Chromium | Not more than 100 mg/kg |
| Copper | Not more than 25 mg/kg |
| Nickel | Not more than 50 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 2 mg/kg |
| Lead | Not more than 5 mg/kg |
E 556 CALCIUM ALUMINIUM SILICATE
(19)
| Synonyms | Calcium aluminosilicate; Calcium silicoaluminate; Aluminium calcium silicate |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium aluminium silicate |
| Chemical formula | |
| Molecular weight | |
| Assay | Content on the anhydrous basis: — as SiO2 not less than 44,0 % and not more than 50,0 % — as Al2O3 not less than 3,0 % and not more than 5,0 % — as CaO not less than 32,0 % and not more than 38,0 % |
| Description | Fine white, free-flowing powder |
| Identification | Identification |
| Test for calcium | Passes test |
| Test for aluminium | Passes test |
| Test for silicate | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 10,0 % (105 °C, 2 hours) |
| Loss on ignition | Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 °C, constant weight) |
| Fluoride | Not more than 50 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 559 ALUMINIUM SILICATE (KAOLIN)
(20)
| Synonyms | Kaolin, light or heavy | Kaolin, light or heavy |
| Definition | Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos | Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos |
| Einecs | 215-286-4 (kaolinite) | 215-286-4 (kaolinite) |
| Chemical name | ||
| Chemical formula | Al2Si2O5(OH)4 (kaolinite) | Al2Si2O5(OH)4 (kaolinite) |
| Molecular weight | 264 | 264 |
| Assay | Content not less than 90 % (sum of silica and alumina, after ignition) | Content not less than 90 % (sum of silica and alumina, after ignition) |
| Assay | Silica (SiO2) | Between 45 % and 55 % |
| Assay | Alumina (Al2O3) | Between 30 % and 39 % |
| Description | Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes | Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes |
| Identification | Identification | Identification |
| Test for alumina | Passes test | Passes test |
| Test for silicate | Passes test | Passes test |
| X-ray diffraction | Characteristic peaks at 7,18/3,58/2,38/1,78 Å | Characteristic peaks at 7,18/3,58/2,38/1,78 Å |
| Infrared absorption spectrum | Peaks at 3 700 and 3 620 cm-1 | Peaks at 3 700 and 3 620 cm-1 |
| Purity | Purity | Purity |
| Loss on ignition | Between 10 and 14 % (1 000 °C, constant weight) | Between 10 and 14 % (1 000 °C, constant weight) |
| Water soluble matter | Not more than 0,3 % | Not more than 0,3 % |
| Acid soluble matter | Not more than 2 % | Not more than 2 % |
| Iron | Not more than 5 % | Not more than 5 % |
| Potassium oxide (K2O) | Not more than 5 % | Not more than 5 % |
| Carbon | Not more than 0,5 % | Not more than 0,5 % |
| Arsenic | Not more than 3 mg/kg | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg | Not more than 1 mg/kg |
E 570 FATTY ACIDS
| Synonyms | |
| Definition | Linear fatty acids, caprylic acid (C8), capric acid (C10), lauric acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1) |
| Einecs | |
| Chemical name | Octanoic acid (C8); decanoic acid (C10); dodecanoic acid (C12); tetradecanoic acid (C14); hexadecanoic acid (C16); octadecanoic acid (C18); 9-octadecenoic acid (C18:1) |
| Chemical formula | |
| Molecular weight | |
| Assay | Not less than 98 % by chromatography |
| Description | A colourless liquid or white solid obtained from oils and fats |
| Identification | Identification |
| Identification test | Individual fatty acids can be identified by acid value, iodine value, gas chromatography |
| Purity | Purity |
| Residue on ignition | Not more than 0,1 % |
| Unsaponifiable matter | Not more than 1,5 % |
| Water content | Not more than 0,2 % (Karl Fischer method) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 574 GLUCONIC ACID
| Synonyms | D-gluconic acid; Dextronic acid |
| Definition | Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone |
| Einecs | |
| Chemical name | Gluconic acid |
| Chemical formula | C6H12O7 (gluconic acid) |
| Molecular weight | 196,2 |
| Assay | Content not less than 49,0 % (as gluconic acid) |
| Description | Colourless to light yellow, clear syrupy liquid |
| Identification | Identification |
| Formation of phenylhydrazine derivative | Positive. Compound formed melts between 196 °C and 202 °C with decomposition |
| Purity | Purity |
| Residue on ignition | Not more than 1,0 % 550 °C +/– 20 °C till disappearance of organic residues (black spots). |
| Reducing matter | Not more than 2,0 % (as D-glucose) |
| Chloride | Not more than 350 mg/kg |
| Sulphate | Not more than 240 mg/kg |
| Sulphite | Not more than 20 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 575 GLUCONO-DELTA-LACTONE
| Synonyms | Gluconolactone; GDL; D-Gluconic acid delta-lactone; Delta-gluconolactone |
| Definition | Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 % - 66 %) and the delta- and gamma-lactones |
| Einecs | 202-016-5 |
| Chemical name | D-Glucono-1,5-lactone |
| Chemical formula | C6H10O6 |
| Molecular weight | 178,14 |
| Assay | Content not less than 99,0 % on the anhydrous basis |
| Description | Fine, white, nearly odourless, crystalline powder |
| Identification | Identification |
| Formation of phenylhydrazine derivative of gluconic acid | Positive. Compound formed melts between 196 °C and 202 °C with decomposition |
| Solubility | Freely soluble in water. Sparingly soluble in ethanol |
| Purity | Purity |
| Water content | Not more than 0,2 % (Karl Fischer method) |
| Reducing substances | Not more than 0,5 % (as D-glucose) |
| Lead | Not more than 1 mg/kg |
E 576 SODIUM GLUCONATE
| Synonyms | Sodium salt of D-gluconic acid |
| Definition | Manufactured by fermentation or chemical catalytic oxidation |
| Einecs | 208-407-7 |
| Chemical name | Sodium D-gluconate |
| Chemical formula | C6H11NaO7 (anhydrous) |
| Molecular weight | 218,14 |
| Assay | Content not less than 99,0 % |
| Description | White to tan, granular to fine, crystalline powder |
| Identification | Identification |
| Test for sodium | Passes test |
| Test for gluconate | Passes test |
| Solubility | Very soluble in water. Sparingly soluble in ethanol |
| pH | Between 6,5 and 7,5 (10 % solution) |
| Purity | Purity |
| Reducing matter | Not more than 1,0 % (as D-glucose) |
| Lead | Not more than 1 mg/kg |
E 577 POTASSIUM GLUCONATE
| Synonyms | Potassium salt of D-gluconic acid |
| Definition | Definition |
| Einecs | 206-074-2 |
| Chemical name | Potassium D-gluconate |
| Chemical formula | C6H11KO7 (anhydrous) C6H11KO7 · H2O (monohydrate) |
| Molecular weight | 234,25 (anhydrous) 252,26 (monohydrate) |
| Assay | Content not less than 97,0 % and not more than 103,0 % on dried basis |
| Description | Odourless, free flowing white to yellowish white, crystalline powder or granules |
| Identification | Identification |
| Test for potassium | Passes test |
| Test for gluconate | Passes test |
| pH | Between 7,0 and 8,3 (10 % solution) |
| Purity | Purity |
| Loss on drying | Anhydrous: not more than 3,0 % (105 °C, 4 hours, vacuum) Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4 hours, vacuum) |
| Reducing substances | Not more than 1,0 % (as D-glucose) |
| Lead | Not more than 2 mg/kg |
E 578 CALCIUM GLUCONATE
| Synonyms | Calcium salt of D-gluconic acid |
| Definition | Definition |
| Einecs | 206-075-8 |
| Chemical name | Calcium di-D-gluconate |
| Chemical formula | C12H22CaO14 (anhydrous) C12H22CaO14 · H2O (monohydrate) |
| Molecular weight | 430,38 (anhydrous form) 448,39 (monohydrate) |
| Assay | anhydrous: Content not less than 98 % and not more than 102 % on the dried basis monohydrate: not less than 98 % and not more than 102 % on the ‘as is’ basis. |
| Description | Odourless, white crystalline granules or powder, stable in air |
| Identification | Identification |
| Test for calcium | Passes test |
| Test for gluconate | Passes test |
| Solubility | Soluble in water, insoluble in ethanol |
| pH | Between 6,0 and 8,0 (5 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 3,0 % (105 °C, 16 hours) (anhydrous) Not more than 2,0 % (105 °C, 16 hours) (monohydrate) |
| Reducing substances | Not more than 1,0 % (as D-glucose) |
| Lead | Not more than 2 mg/kg |
E 579 FERROUS GLUCONATE
| Synonyms | |
| Definition | Definition |
| Einecs | 206-076-3 |
| Chemical name | Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate |
| Chemical formula | C12H22FeO14·2H2O |
| Molecular weight | 482,17 |
| Assay | Content not less than 95 % on the dried basis |
| Description | Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar |
| Identification | Identification |
| Solubility | Soluble with slight heating in water. Practically insoluble in ethanol |
| Test for ferrous ion | Passes test |
| Formation of phenylhy-drazine derivative of gluconic acid | Positive |
| pH | Between 4 and 5,5 (10 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 10 % (105 °C, 16 hours) |
| Oxalic acid | Not detectable |
| Iron (Fe III) | Not more than 2 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
| Reducing substances | Not more than 0,5 % expressed as glucose |
E 585 FERROUS LACTATE
| Synonyms | Iron(II) lactate; Iron(II) 2-hydroxy propanoate; Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1) |
| Definition | Definition |
| Einecs | 227-608-0 |
| Chemical name | Ferrous 2-hydroxy propanoate |
| Chemical formula | C6H10FeO6· nH2O (n = 2 or 3) |
| Molecular weight | 270,02 (dihydrate) 288,03 (trihydrate) |
| Assay | Content not less than 96 % on the dried basis |
| Description | Greenish-white crystals or light green powder having a characteristic smell |
| Identification | Identification |
| Solubility | Soluble in water. Practically insoluble in ethanol |
| Test for ferrous ion | Passes test |
| Test for lactate | Passes test |
| pH | Between 4 and 6 (2 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 18 % (100 °C, under vacuum, approximately 700 mm Hg) |
| Iron (Fe III) | Not more than 0,6 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
E 586 4-HEXYLRESORCINOL
| Synonyms | 4-Hexyl-1,3-benzenediol; Hexylresorcinol |
| Definition | Definition |
| Einecs | 205-257-4 |
| Chemical name | 4-Hexylresorcinol |
| Chemical formula | C12H18O2 |
| Molecular weight | 197,24 |
| Assay | Not less than 98 % on the dried basis (4 hours at room temperature) |
| Description | White powder |
| Identification | Identification |
| Solubility | Freely soluble in ether and acetone; very slightly soluble in water |
| Nitric acid test | To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears |
| Bromine test | To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution |
| Purity | Purity |
| Melting range | 62 to 67 °C |
| Acidity | Not more than 0,05 % |
| Sulphated ash | Not more than 0,1 % |
| Resorcinol and other phenols | Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced |
| Nickel | Not more than 2 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 3 mg/kg |
E 620 GLUTAMIC ACID
| Synonyms | L-Glutamic acid; L-α-Aminoglutaric acid |
| Definition | Definition |
| Einecs | 200-293-7 |
| Chemical name | L-Glutamic acid; L-2-amino-pentanedioic acid |
| Chemical formula | C5H9NO4 |
| Molecular weight | 147,13 |
| Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis |
| Solubility | Sparingly soluble in water; practically insoluble in ethanol or ether |
| Description | White crystals or crystalline powder |
| Identification | Identification |
| Test for glutamic acid (by thin layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 31,5° and + 32,2° (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| pH | Between 3,0 and 3,5 (saturated solution) |
| Purity | Purity |
| Loss on drying | Not more than 0,2 % (80 °C, 3 hours) |
| Sulphated ash | Not more than 0,2 % |
| Chloride | Not more than 0,2 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Arsenic | Not more than 2,5 mg/kg |
| Lead | Not more than 1 mg/kg |
E 621 MONOSODIUM GLUTAMATE
| Synonyms | Sodium glutamate; MSG |
| Definition | Definition |
| Einecs | 205-538-1 |
| Chemical name | Monosodium L-glutamate monohydrate |
| Chemical formula | C5H8NaNO4 · H2O |
| Molecular weight | 187,13 |
| Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis |
| Solubility | Freely soluble in water; practically insoluble in ethanol or ether |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | Identification |
| Test for sodium | Passes test |
| Test for glutamic acid (by thin-layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 24,8° and + 25,3° (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| pH | Between 6,7 and 7,2 (5 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (98 °C, 5 hours) |
| Chloride | Not more than 0,2 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Lead | Not more than 1 mg/kg |
E 622 MONOPOTASSIUM GLUTAMATE
| Synonyms | Potassium glutamate; MPG |
| Definition | Definition |
| Einecs | 243-094-0 |
| Chemical name | Monopotassium L-glutamate monohydrate |
| Chemical formula | C5H8KNO4 · H2O |
| Molecular weight | 203,24 |
| Assay | Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis |
| Solubility | Freely soluble in water; practically insoluble in ethanol or ether |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | Identification |
| Test for potassium | Passes test |
| Test for glutamic acid (by thin-layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 22,5° and + 24,0° (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| pH | Between 6,7 and 7,3 (2 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 0,2 % (80 °C, 5 hours) |
| Chloride | Not more than 0,2 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Lead | Not more than 1 mg/kg |
E 623 CALCIUM DIGLUTAMATE
| Synonyms | Calcium glutamate |
| Definition | Definition |
| Einecs | 242-905-5 |
| Chemical name | Monocalcium di-L-glutamate |
| Chemical formula | C10H16CaN2O8 · nH2O (n = 0, 1, 2 or 4) |
| Molecular weight | 332,32 (anhydrous) |
| Assay | Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis |
| Solubility | Freely soluble in water; practically insoluble in ethanol or ether |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | Identification |
| Test for calcium | Passes test |
| Test for glutamic acid (by thin-layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 27,4° and + 29,2° (for calcium diglutamate with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| Purity | Purity |
| Water content | Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl Fischer) |
| Chloride | Not more than 0,2 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Lead | Not more than 1 mg/kg |
E 624 MONOAMMONIUM GLUTAMATE
| Synonyms | Ammonium glutamate |
| Definition | Definition |
| Einecs | 231-447-1 |
| Chemical name | Monoammonium L-glutamate monohydrate |
| Chemical formula | C5H12N2O4 · H2O |
| Molecular weight | 182,18 |
| Assay | Content not less than 99,0 % and not more 101,0 % on the anhydrous basis |
| Solubility | Freely soluble in water; practically insoluble in ethanol or ether |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | Identification |
| Test for ammonium | Passes test |
| Test for glutamic acid (by thin-layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 25,4° and + 26,4° (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| pH | Between 6,0 and 7,0 (5 % solution) |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (50 °C, 4 hours) |
| Sulphated ash | Not more than 0,1 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Lead | Not more than 1 mg/kg |
E 625 MAGNESIUM DIGLUTAMATE
| Synonyms | Magnesium glutamate |
| Definition | Definition |
| Einecs | 242-413-0 |
| Chemical name | Monomagnesium di-L-glutamate tetrahydrate |
| Chemical formula | C10H16MgN2O8 · 4H2O |
| Molecular weight | 388,62 |
| Assay | Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis |
| Solubility | Very soluble in water; practically insoluble in ethanol or ether |
| Description | Odourless, white or off-white crystals or powder |
| Identification | Identification |
| Test for magnesium | Passes test |
| Test for glutamic acid (by thin-layer chromatography) | Passes test |
| Specific rotation | [α]D 20 between + 23,8° and + 24,4° (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube) |
| pH | Between 6,4 and 7,5 (10 % solution) |
| Purity | Purity |
| Water content | Not more than 24 % (Karl Fischer) |
| Chloride | Not more than 0,2 % |
| Pyrrolidone carboxylic acid | Not more than 0,2 % |
| Lead | Not more than 1 mg/kg |
E 626 GUANYLIC ACID
| Synonyms | 5'-Guanylic acid |
| Definition | Definition |
| Einecs | 201-598-8 |
| Chemical name | Guanosine-5'-monophosphoric acid |
| Chemical formula | C10H14N5O8P |
| Molecular weight | 363,22 |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Slightly soluble in water, practically insoluble in ethanol |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| pH | Between 1,5 and 2,5 (0,25 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm |
| Purity | Purity |
| Loss on drying | Not more than 1,5 % (120 °C, 4 hours) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 627 DISODIUM GUANYLATE
| Synonyms | Sodium guanylate; Sodium 5'-guanylate |
| Definition | Definition |
| Einecs | 226-914-1 |
| Chemical name | Disodium guanosine-5'-monophosphate |
| Chemical formula | C10H12N5Na2O8P · nH2O (n = ca. 7) |
| Molecular weight | 407,19 (anhydrous) |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Soluble in water, sparingly soluble in ethanol, practically insoluble in ether |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for sodium | Passes test |
| pH | Between 7,0 and 8,5 (5 % solution) |
| Spectrometry | maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm |
| Purity | Purity |
| Loss on drying | Not more than 25 % (120 °C, 4 hours) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 628 DIPOTASSIUM GUANYLATE
| Synonyms | Potassium guanylate; Potassium 5'-guanylate |
| Definition | Definition |
| Einecs | 221-849-5 |
| Chemical name | Dipotassium guanosine-5'-monophosphate |
| Chemical formula | C10H12K2N5O8P |
| Molecular weight | 439,40 |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Freely soluble in water, practically insoluble in ethanol |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for potassium | Passes test |
| pH | Between 7,0 and 8,5 (5 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm |
| Purity | Purity |
| Loss on drying | Not more than 5 % (120 °C, 4 hours) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 629 CALCIUM GUANYLATE
| Synonyms | Calcium 5'-guanylate |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium guanosine-5'-monophosphate |
| Chemical formula | C10H12CaN5O8P · nH2O |
| Molecular weight | 401,20 (anhydrous) |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Sparingly soluble in water |
| Description | Odourless, white or off-white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for calcium | Passes test |
| pH | Between 7,0 and 8,0 (0,05 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm |
| Purity | Purity |
| Loss on drying | Not more than 23,0 % (120 °C, 4 hours) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 630 INOSINIC ACID
| Synonyms | 5'-Inosinic acid |
| Definition | Definition |
| Einecs | 205-045-1 |
| Chemical name | Inosine-5'-monophosphoric acid |
| Chemical formula | C10H13N4O8P |
| Molecular weight | 348,21 |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Freely soluble in water, slightly soluble in ethanol |
| Description | Odourless, colourless or white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| pH | Between 1,0 and 2,0 (5 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm |
| Purity | Purity |
| Loss on drying | Not more than 3,0 % (120 °C, 4 hours) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 631 DISODIUM INOSINATE
| Synonyms | Sodium inosinate; Sodium 5'-inosinate |
| Definition | Definition |
| Einecs | 225-146-4 |
| Chemical name | Disodium inosine-5'-monophosphate |
| Chemical formula | C10H11N4Na2O8P · H2O |
| Molecular weight | 392,17 (anhydrous) |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Soluble in water, sparingly soluble in ethanol, practically insoluble in ether |
| Description | Odourless, colourless or white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for sodium | Passes test |
| pH | Between 7,0 and 8,5 |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm |
| Purity | Purity |
| Water content | Not more than 28,5 % (Karl Fischer) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 632 DIPOTASSIUM INOSINATE
| Synonyms | Potassium inosinate; Potassium 5'-inosinate |
| Definition | Definition |
| Einecs | 243-652-3 |
| Chemical name | Dipotassium inosine-5'-monophosphate |
| Chemical formula | C10H11K2N4O8P |
| Molecular weight | 424,39 |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Freely soluble in water; practically insoluble in ethanol |
| Description | Odourless, colourless or white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for potassium | Passes test |
| pH | Between 7,0 and 8,5 (5 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm |
| Purity | Purity |
| Water content | Not more than 10,0 % (Karl Fischer) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 633 CALCIUM INOSINATE
| Synonyms | Calcium 5'-inosinate |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium inosine-5'-monophosphate |
| Chemical formula | C10H11CaN4O8P · nH2O |
| Molecular weight | 386,19 (anhydrous) |
| Assay | Content not less than 97,0 % on the anhydrous basis |
| Solubility | Sparingly soluble in water |
| Description | Odourless, colourless or white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for calcium | Passes test |
| pH | Between 7,0 and 8,0 (0,05 % solution) |
| Spectrometry | Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm |
| Purity | Purity |
| Water content | Not more than 23,0 % (Karl Fischer) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 634 CALCIUM 5'-RIBONUCLEOTIDE
| Synonyms | |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium 5′-ribonucleotide is essentially a mixture of calcium inosine-5′-monophosphate and calcium guanosine-5′-monophosphate |
| Chemical formula | C10H11N4CaO8P · nH2O C10H12N5CaO8P · nH2O |
| Molecular weight | |
| Assay | Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis |
| Solubility | Sparingly soluble in water |
| Description | Odourless, white or nearly white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for calcium | Passes test |
| pH | Between 7,0 and 8,0 (0,05 % solution) |
| Purity | Purity |
| Water content | Not more than 23,0 % (Karl Fischer) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 635 DISODIUM 5'-RIBONUCLEOTIDE
| Synonyms | Sodium 5'-ribonucleotide |
| Definition | Definition |
| Einecs | |
| Chemical name | Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate |
| Chemical formula | C10H11N4O8P · nH2O C10H12N5Na2O8P · nH2O |
| Molecular weight | |
| Assay | Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis |
| Solubility | Soluble in water, sparingly soluble in ethanol practically insoluble in ether |
| Description | Odourless, white or nearly white crystals or powder |
| Identification | Identification |
| Test for ribose | Passes test |
| Test for organic phosphate | Passes test |
| Test for sodium | Passes test |
| pH | Between 7,0 and 8,5 (5 % solution) |
| Purity | Purity |
| Water content | Not more than 26,0 % (Karl Fischer) |
| Other nucleotides | Not detectable by thin-layer chromatography |
| Lead | Not more than 1 mg/kg |
E 640 GLYCINE AND ITS SODIUM SALT
(i) GLYCINE
| Synonyms | Aminoacetic acid; Glycocoll |
| Definition | Definition |
| Einecs | 200-272-2 |
| Chemical name | Aminoacetic acid |
| Chemical formula | C2H5NO2 |
| Molecular weight | 75,07 |
| Assay | Content not less than 98,5 % on the anhydrous basis |
| Description | White crystals or crystalline powder |
| Identification | Identification |
| Test for amino acid | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 0,2 % (105 °C, 3 hours) |
| Residue on ignition | Not more than 0,1 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
(ii) SODIUM GLYCINATE
| Synonyms | |
| Definition | Definition |
| Einecs | 227-842-3 |
| Chemical name | Sodium glycinate |
| Chemical formula | C2H5NO2 Na |
| Molecular weight | 98 |
| Assay | Content not less than 98,5 % on the anhydrous basis |
| Description | White crystals or crystalline powder |
| Identification | Identification |
| Test for amino acid | Passes test |
| Test for sodium | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 0,2 % (105 °C, 3 hours) |
| Residue on ignition | Not more than 0,1 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 641 L-LEUCINE
| Synonyms | 2-Aminoisobutylacetic acid; L-2-Amino-4-methylvaleric acid; alpha-Aminoisocaproic acid; (S)-2-Amino-4-methylpentanoic acid; L-Leu |
| Definition | Definition |
| Einecs | 200-522-0 |
| CAS number | 61-90-5 |
| Chemical name | L-Leucine; L-2-Amino-4-methylpentanoic acid |
| Chemical formula | C6H13NO2 |
| Molecular Weight | 131,17 |
| Assay | Content not less than 98,5 % and not more than 101,0 % on the anhydrous basis |
| Description | White or almost white crystalline powder or shiny flakes |
| Identification | Identification |
| Solubility | Soluble in water, acetic acid, dilute HCl and alkaline hydroxides and carbonates; slightly soluble in ethanol |
| Specific rotation | [α]D 20 between + 14,5° and + 16,5° (4 % solution (anhydrous basis) in 6N HCl) |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (100 °C – 105 °C) |
| Sulphated Ash | Not more than 0,1 % |
| Chlorides | Not more than 200 mg/kg |
| Sulphates | Not more than 300 mg/kg |
| Ammonium | Not more than 200 mg/kg |
| Iron | Not more than 10 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 650 ZINC ACETATE
| Synonyms | Acetic acid, zinc salt, dihydrate |
| Definition | Definition |
| Einecs | |
| Chemical name | Zinc acetate dihydrate |
| Chemical formula | C4H6O4 Zn · 2H2O |
| Molecular weight | 219,51 |
| Assay | Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O |
| Description | Colourless crystals or fine, off-white powder |
| Identification | Identification |
| Test for acetate | Passes test |
| Test for zinc | Passes test |
| pH | Between 6,0 and 8,0 (5 % solution) |
| Purity | Purity |
| Water insoluble matter | Not more than 0,005 % |
| Chlorides | Not more than 50 mg/kg |
| Sulphates | Not more than 100 mg/kg |
| Alkalines and alkaline earths | Not more than 0,2 % |
| Organic volatile impurities | Passes test |
| Iron | Not more than 50 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 20 mg/kg |
| Cadmium | Not more than 5 mg/kg |
E 900 DIMETHYL POLYSILOXANE
| Synonyms | Polydimethyl siloxane; Silicone fluid; Silicone oil; Dimethyl silicone |
| Definition | Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stabilised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO |
| Einecs | |
| Chemical name | Siloxanes and silicones, di-methyl |
| Chemical formula | (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3 |
| Molecular weight | |
| Assay | Content of total silicon not less than 37,3 % and not more than 38,5 % |
| Description | Clear, colourless, viscous liquid |
| Identification | Identification |
| Specific gravity (25° C/25 °C) | Between 0,964 and 0,977 |
| Refractive index | [n]D 25 between 1,400 and 1,405 |
| Infrared absorption spectrum | The infrared absorption spectrum of a liquid film of the sample between two sodium chloride plates exhibits relative maxima at the same wavelengths as those of a similar preparation of Dimethylpolysiloxane Reference Standard |
| Purity | Purity |
| Loss on drying | Not more than 0,5 % (150 °C, 4h) |
| Viscosity | Not less than 1,00 · 10– 4 m2s– 1 at 25 °C |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 901 BEESWAX, WHITE AND YELLOW
| Synonyms | White wax; Yellow wax |
| Definition | Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter White beeswax is obtained by bleaching yellow beeswax |
| Einecs | 232-383-7 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour |
| Identification | Identification |
| Melting range | Between 62 °C and 65 °C |
| Specific gravity | About 0,96 |
| Solubility | Insoluble in water, sparingly soluble in alcohol, very soluble in chloroform and ether |
| Purity | Purity |
| Acid value | Not less than 17 and not more than 24 |
| Saponification value | 87-104 |
| Peroxide value | Not more than 5 |
| Glycerol and other polyols | Not more than 0,5 % (as glycerol) |
| Ceresin, paraffins and certain other waxes | Transfer 3,0 g of the sample to a 100 ml round-bottomed flask, add 30 ml of a 4% w/v solution of potassium hydroxide in aldehyde-free ethanol and boil gently under a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80 °C and allow to cool, swirling the solution continuously. No precipitate is formed before the temperature reaches 65 °C, although the solution may be opalescent. |
| Fats, Japan wax, rosin and soaps | Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 solution of sodium hydroxide, maintaining the volume by the occasional addition of water, and cool the mixture. The wax separates and the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydrochloric acid. No precipitate is formed. |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 902 CANDELILLA WAX
| Synonyms | |
| Definition | Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica |
| Einecs | 232-347-0 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Hard, yellowish brown, opaque to translucent wax |
| Identification | Identification |
| Specific gravity | About 0,98 |
| Melting range | Between 68,5 °C and 72,5 °C |
| Solubility | Insoluble in water, soluble in chloroform and toluene |
| Purity | Purity |
| Acid value | Not less than 12 and not more than 22 |
| Saponification value | Not less than 43 and not more than 65 |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 903 CARNAUBA WAX
| Synonyms | |
| Definition | Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera |
| Einecs | 232-399-4 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture |
| Identification | Identification |
| Specific gravity | About 0,997 |
| Melting range | Between 82 °C and 86 °C |
| Solubility | Insoluble in water, partly soluble in boiling ethanol, soluble in chloroform and diethyl ether |
| Purity | Purity |
| Sulphated ash | Not more than 0,25 % |
| Acid value | Not less than 2 and not more than 7 |
| Ester value | Not less than 71 and not more than 88 |
| Unsaponifiable matter | Not less than 50 % and not more than 55 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 904 SHELLAC
| Synonyms | Bleached shellac; White shellac |
| Definition | Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae). The wax is removed by filtration. |
| Einecs | 232-549-9 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Wax-free bleached shellac – off-white to light yellow, amorphous, granular resin |
| Identification | Identification |
| Solubility | Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone |
| Acid value | Between 60 and 89 |
| Purity | Purity |
| Loss on drying | Not more than 6,0 % (40 °C, over silica gel, 15 hours) |
| Rosin | Absent |
| Wax | not more than 0,2 % |
| Lead | Not more than 2 mg/kg |
E 905 MICROCRYSTALLINE WAX
| Synonyms | Petroleum wax; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic wax; Synthetic paraffin |
| Definition | Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks |
| Description | White to amber, odourless wax |
| Identification | Identification |
| Solubility | Insoluble in water, very slightly soluble in ethanol |
| Refractive index | [n]D 100 1,434-1,448 Alternative [n]D 1201,426-1,440 |
| Purity | Purity |
| Molecular weight | Average not less than 500 |
| Viscosity | Not less than 1,1 × 10– 5 m2s– 1at 100 °C Alternative: Not less than 0,8 × 10– 5 m2s– 1at 120 °C, if solid at 100 °C |
| Residue on ignition | Not more than 0,1 % |
| Carbon number at 5 % distillation point | Not more than 5 % of molecules with carbon number less than 25 |
| Colour | Passes test |
| Sulphur | Not more than 0,4 wt % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 3 mg/kg |
| Polycyclic aromatic compounds | Benzo(a)pyrene no more than 50 μg/kg |
E 907 HYDROGENATED POLY-1-DECENE
| Synonyms | Hydrogenated polydec-1-ene; Hydrogenated poly-alpha-olefin |
| Definition | Definition |
| Einecs | |
| Chemical name | |
| Chemical formula | C10nH20n+2 where n = 3-6 |
| Molecular weight | 560 (average) |
| Assay | Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution: C30: 13-37 % C40: 35-70 % C50: 9-25 % C60: 1-7 % |
| Description | |
| Identification | Identification |
| Solubility | Insoluble in water; slightly soluble in ethanol; soluble in toluene |
| Burning | Burns with a bright flame and a paraffin-like characteristic smell |
| Viscosity | Between 5,7 × 10– 6 and 6,1 × 10– 6 m2s– 1 at 100 °C |
| Purity | Purity |
| Compounds with carbon number less than 30 | Not more than 1,5 % |
| Readily carbonisable substances | After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour |
| Nickel | Not more than 1 mg/kg |
| Lead | Not more than 1 mg/kg |
E 914 OXIDISED POLYETHYLENE WAX
| Synonyms | |
| Definition | Polar reaction products from mild oxidation of polyethylene |
| Einecs | |
| Chemical name | Oxidised polyethylene |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Almost white flakes, powder, granules or pellets |
| Identification | Identification |
| Density | Between 0,92 and 1,05 (20 °C) |
| Drop point | Greater than 95 °C |
| Purity | Purity |
| Acid value | Not more than 70 |
| Viscosity | Not less than 8,1 · 10– 5 m2s– 1 at 120 °C |
| Other wax types | Not detectable (by differential scanning calorimetry and/or infrared spectroscopy) |
| Oxygen | Not more than 9,5 % |
| Chromium | Not more than 5 mg/kg |
| Lead | Not more than 2 mg/kg |
E 920 L-CYSTEINE
| Synonyms | |
| Definition | L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance |
| Einecs | 200-157-7 (anhydrous) |
| Chemical name | |
| Chemical formula | C3H7NO2S · HCl · nH2O (where n = 0 or 1) |
| Molecular weight | 157,62 (anhydrous) |
| Assay | Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis |
| Description | White powder or colourless crystals |
| Identification | Identification |
| Solubility | Freely soluble in water and in ethanol |
| Melting range | Anhydrous form melts at about 175 °C |
| Specific rotation | [α]D 20: between + 5,0° and + 8,0° or [α]D 25: between + 4,9° and 7,9° |
| Purity | Purity |
| Loss on drying | Between 8,0 % and 12,0 % Not more than 2,0 % (anhydrous form) |
| Residue on ignition | Not more than 0,1 % |
| Ammonium-ion | Not more than 200 mg/kg |
| Arsenic | Not more than 1,5 mg/kg |
| Lead | Not more than 5 mg/kg |
E 927b CARBAMIDE
| Synonyms | Urea |
| Definition | Definition |
| Einecs | 200-315-5 |
| Chemical name | |
| Chemical formula | CH4N2O |
| Molecular weight | 60,06 |
| Assay | Content not less than 99,0 % on the anhydrous basis |
| Description | Colourless to white, prismatic, crystalline powder or small, white pellets |
| Identification | Identification |
| Solubility | Very soluble in water Soluble in ethanol |
| Precipitation with nitric acid | To pass the test a white, crystalline precipitate is formed |
| Colour reaction | To pass the test a reddish-violet colour is produced |
| Melting range | 132 °C to 135 °C |
| Purity | Purity |
| Loss on drying | Not more than 1,0 % (105 °C, 1 hour) |
| Sulphated ash | Not more than 0,1 % |
| Ethanol-insoluble matter | Not more than 0,04 % |
| Alkalinity | Passes test |
| Ammonium-ion | Not more than 500 mg/kg |
| Biuret | Not more than 0,1 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
E 938 ARGON
| Synonyms | |
| Definition | Definition |
| Einecs | 231-147-0 |
| Chemical name | Argon |
| Chemical formula | Ar |
| Atomic weight | 40 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,05 % |
| Methane and other hydrocarbons | Not more than 100 μl/l (calculated as methane) |
E 939 HELIUM
| Synonyms | |
| Definition | Definition |
| Einecs | 231-168-5 |
| Chemical name | Helium |
| Chemical formula | He |
| Atomic weight | 4 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,05 % |
| Methane and other hydrocarbons | Not more than 100 μl/l (calculated as methane) |
E 941 NITROGEN
| Synonyms | |
| Definition | Definition |
| Einecs | 231-783-9 |
| Chemical name | Nitrogen |
| Chemical formula | N2 |
| Molecular weight | 28 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,05 % |
| Carbon monoxide | Not more than 10 μl/l |
| Methane and other hydrocarbons | Not more than 100 μl/l (calculated as methane) |
| Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/l |
| Oxygen | Not more than 1 % |
E 942 NITROUS OXIDE
| Synonyms | |
| Definition | Definition |
| Einecs | 233-032-0 |
| Chemical name | Nitrous oxide |
| Chemical formula | N2O |
| Molecular weight | 44 |
| Assay | Not less than 99 % |
| Description | Colourless, non-flammable gas, sweetish odour |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,05 % |
| Carbon monoxide | Not more than 30 μl/l |
| Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/l |
E 943a BUTANE
| Synonyms | n-Butane |
| Definition | Definition |
| Einecs | |
| Chemical name | Butane |
| Chemical formula | CH3CH2CH2CH3 |
| Molecular weight | 58,12 |
| Assay | Content not less than 96 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | Identification |
| Vapour pressure | 108,935 kPa at 20 °C |
| Purity | Purity |
| Methane | Not more than 0,15 % v/v |
| Ethane | Not more than 0,5 % v/v |
| Propane | Not more than 1,5 % v/v |
| Isobutane | Not more than 3,0 % v/v |
| 1,3-butadiene | Not more than 0,1 % v/v |
| Moisture | Not more than 0,005 % |
E 943b ISOBUTANE
| Synonyms | 2-Methyl propane |
| Definition | Definition |
| Einecs | |
| Chemical name | 2-methyl propane |
| Chemical formula | (CH3)2CH CH3 |
| Molecular weight | 58,12 |
| Assay | Content not less than 94 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | Identification |
| Vapour pressure | 205,465 kPa at 20 °C |
| Purity | Purity |
| Methane | Not more than 0,15 % v/v |
| Ethane | Not more than 0,5 % v/v |
| Propane | Not more than 2,0 % v/v |
| n-Butane | Not more than 4,0 % v/v |
| 1,3-butadiene | Not more than 0,1 % v/v |
| Moisture | Not more than 0,005 % |
E 944 PROPANE
| Synonyms | |
| Definition | Definition |
| Einecs | |
| Chemical name | Propane |
| Chemical formula | CH3CH2CH3 |
| Molecular weight | 44,09 |
| Assay | Content not less than 95 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | Identification |
| Vapour pressure | 732,910 kPa at 20 °C |
| Purity | Purity |
| Methane | Not more than 0,15 % v/v |
| Ethane | Not more than 1,5 % v/v |
| Isobutane | Not more than 2,0 % v/v |
| n-Butane | Not more than 1,0 % v/v |
| 1,3-butadiene | Not more than 0,1 % v/v |
| Moisture | Not more than 0,005 % |
E 948 OXYGEN
| Synonyms | |
| Definition | Definition |
| Einecs | 231-956-9 |
| Chemical name | Oxygen |
| Chemical formula | O2 |
| Molecular weight | 32 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,05 % |
| Methane and other hydrocarbons | Not more than 100 μl/l (calculated as methane) |
E 949 HYDROGEN
| Synonyms | |
| Definition | Definition |
| Einecs | 215-605-7 |
| Chemical name | Hydrogen |
| Chemical formula | H2 |
| Molecular weight | 2 |
| Assay | Content not less than 99,9 % |
| Description | Colourless, odourless, highly flammable gas |
| Identification | |
| Purity | Purity |
| Water content | Not more than 0,005 % v/v |
| Oxygen | Not more than 0,001 % v/v |
| Nitrogen | Not more than 0,07 % v/v |
E 950 ACESULFAME K
| Synonyms | Acesulfame potassium; Potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one-2,2-dioxide |
| Definition | Definition |
| Einecs | 259-715-3 |
| Chemical name | 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt |
| Chemical formula | C4H4KNO4S |
| Molecular weight | 201,24 |
| Assay | Content not less than 99 % of C4H4KNO4S on the anhydrous basis |
| Description | Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Very soluble in water, very slightly soluble in ethanol |
| Ultraviolet absorption | Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water |
| Test for potassium | Passes test (test the residue obtained by igniting 2 g of the sample) |
| Precipitation test | Add a few drops of a 10 % solution of sodium cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced |
| Purity | Purity |
| Loss on drying | Not more than 1 % (105 °C, 2 hours) |
| Organic impurities | Passes test for 20 mg/kg of UV active components |
| Fluoride | Not more than 3 mg/kg |
| Lead | Not more than 1 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 951 ASPARTAME
| Synonyms | Aspartyl phenylalanine methyl ester |
| Definition | Definition |
| Einecs | 245-261-3 |
| Chemical name | N-L-α-Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester |
| Chemical formula | C14H18N2O5 |
| Molecular weight | 294,31 |
| Assay | Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis |
| Description | White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Slightly soluble in water and in ethanol |
| pH | Between 4,5 and 6,0 (1 in 125 solution) |
| Specific rotation | [α]D 20: + 14,5° to + 16,5° Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution |
| Purity | Purity |
| Loss on drying | Not more than 4,5 % (105 °C, 4 hours) |
| Sulphated ash | Not more than 0,2 % (expressed on dry weight basis) |
| Transmittance | The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022 |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
| 5-Benzyl-3,6-dioxo-2-piperazineacetic acid | Not more than 1,5 % (expressed on dry weight basis) |
E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS
(i) CYCLAMIC ACID
| Synonyms | Cyclohexylsulphamic acid; Cyclamate |
| Definition | Definition |
| Einecs | 202-898-1 |
| Chemical name | Cyclohexanesulphamic acid; cyclohexylaminosulphonic acid |
| Chemical formula | C6H13NO3S |
| Molecular weight | 179,24 |
| Assay | Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis |
| Description | A practically colourless, white crystalline powder. Approximately 40 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Soluble in water and in ethanol |
| Precipitation test | Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms. |
| Purity | Purity |
| Loss on drying | Not more than 1 % (105 °C, 1 hour) |
| Selenium | Not more than 30 mg/kg (expressed as selenium on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Cyclohexylamine | Not more than 10 mg/kg (expressed on dry weight basis) |
| Dicyclohexylamine | Not more than 1 mg/kg (expressed on dry weight basis) |
| Aniline | Not more than 1 mg/kg (expressed on dry weight basis) |
(ii) SODIUM CYCLAMATE
| Synonyms | Cyclamate; Sodium salt of cyclamic acid |
| Definition | Definition |
| Einecs | 205-348-9 |
| Chemical name | Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate |
| Chemical formula | C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O |
| Molecular weight | 201,22 calculated on the anhydrous form 237,22 calculated on the hydrated form |
| Assay | Not less than 98 % and not more than 102 % on the dried basis Dihydrate form: not less than 84 % on the dried basis |
| Description | White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Soluble in water, practically insoluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 1 % (105 °C, 1 hour) Not more than 15,2 % (105 °C, 2 hours) for the dihydrate form |
| Selenium | Not more than 30 mg/kg (expressed as selenium on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
| Cyclohexylamine | Not more than 10 mg/kg (expressed on dry weight basis) |
| Dicyclohexylamine | Not more than 1 mg/kg (expressed on dry weight basis) |
| Aniline | Not more than 1 mg/kg (expressed on dry weight basis) |
(iii) CALCIUM CYCLAMATE
| Synonyms | Cyclamate; Calcium salt of cyclamic acid |
| Definition | Definition |
| Einecs | 205-349-4 |
| Chemical name | Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate |
| Chemical formula | C12H24CaN2O6S2· 2H2O |
| Molecular weight | 432,57 |
| Assay | Not less than 98 % and not more than 101 % on the dried basis |
| Description | White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Soluble in water, sparingly soluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 1 % (105 °C, 1 hour) Not more than 8,5 % (140 °C, 4 hours) for the dihydrate form |
| Selenium | Not more than 30 mg/kg (expressed as selenium on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
| Cyclohexylamine | Not more than 10 mg/kg (expressed on dry weight basis) |
| Dicyclohexylamine | Not more than 1 mg/kg (expressed on dry weight basis) |
| Aniline | Not more than 1 mg/kg (expressed on dry weight basis) |
E 953 ISOMALT
| Synonyms | Hydrogenated isomaltulose. |
| Definition | Manufactured by enzymatic conversion of sucrose with nonviable cells of Protaminobacter rubrum followed by catalytic hydrogenation |
| Einecs | |
| Chemical name | Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides: 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) |
| Chemical formula | 6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O |
| Molecular weight | 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,3 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,3 |
| Assay | Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis. |
| Description | Odourless, white, slightly hygroscopic, crystalline mass or aqueous solution with a minimum concentration of 60 % |
| Identification | Identification |
| Solubility | Soluble in water, very slightly soluble in ethanol. |
| HPLC test | Comparison with an appropriate reference standard of Isomalt shows that the 2 principal peaks in the chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution. |
| Purity | Purity |
| Water content | Not more than 7 % for solid product (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| D-Mannitol | Not more than 3 % |
| D-Sorbitol | Not more than 6 % |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on dry weight basis) |
| Nickel | Not more than 2 mg/kg (expressed on dry weight basis) |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
E 954 SACCHARIN AND ITS Na. K AND Ca SALTS
(i) SACCHARIN
| Synonyms | |
| Definition | Definition |
| Einecs | 201-321-0 |
| Chemical name | 3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide |
| Chemical formula | C7H5NO3S |
| Molecular weight | 183,18 |
| Assay | Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis |
| Description | White crystals or a white crystalline powder, odourless or with a faint, aromatic odour. Approximately between 300 and 500 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 1 % (105 °C, 2 hours) |
| Melting range | 226 to 230 °C |
| Sulphated ash | Not more than 0,2 % (expressed on dry weight basis) |
| Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears |
| o-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| p-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| Benzoic acid p-sulphonamide | Not more than 25 mg/kg (expressed on dry weight basis) |
| Readily carbonisable substances | Absent |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Selenium | Not more than 30 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
(ii) SODIUM SACCHARIN
| Synonyms | Saccharin; Sodium salt of saccharin |
| Definition | Definition |
| Einecs | 204-886-1 |
| Chemical name | Sodium o-benzosulphimide; sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate |
| Chemical formula | C7H4NNaO3S·2H2O |
| Molecular weight | 241,19 |
| Assay | Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis |
| Description | White crystals or a white crystalline efflorescent powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions |
| Identification | Identification |
| Solubility | Freely soluble in water, sparingly soluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 15 % (120 °C, 4 hours) |
| Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears |
| o-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| p-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| Benzoic acid p-sulphonamide | Not more than 25 mg/kg (expressed on dry weight basis) |
| Readily carbonisable substances | Absent |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Selenium | Not more than 30 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
(iii) CALCIUM SACCHARIN
| Synonyms | Saccharin; Calcium salt of saccharin |
| Definition | Definition |
| Chemical name | Calcium o-benzosulphimide; calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7) |
| Einecs | 229-349-9 |
| Chemical formula | C14H8CaN2O6S2·3½H2O |
| Molecular weight | 467,48 |
| Assay | Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis |
| Description | White crystals or a white crystalline powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions |
| Identification | Identification |
| Solubility | Freely soluble in water, soluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 13,5 % (120 °C, 4 hours) |
| Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears |
| o-Toluenesulphonamide | Not more than 10 mg/kg expressed (on dry weight basis) |
| p-Toluenesulphonamide | Not more than 10 mg/kg expressed (on dry weight basis) |
| Benzoic acid p-sulphonamide | Not more than 25 mg/kg expressed (on dry weight basis) |
| Readily carbonisable substances | Absent |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Selenium | Not more than 30 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
(iv) POTASSIUM SACCHARIN
| Synonyms | Saccharin; Potassium salt of saccharin |
| Definition | Definition |
| Einecs | |
| Chemical name | Potassium o-benzosulphimide; potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole; potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate |
| Chemical formula | C7H4KNO3S·H2O |
| Molecular weight | 239,77 |
| Assay | Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis |
| Description | White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose |
| Identification | Identification |
| Solubility | Freely soluble in water, sparingly soluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 8 % (120 °C, 4 hours) |
| Benzoic and salicylic acid | To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears |
| o-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| p-Toluenesulphonamide | Not more than 10 mg/kg (expressed on dry weight basis) |
| Benzoic acid p-sulphonamide | Not more than 25 mg/kg (expressed on dry weight basis) |
| Readily carbonisable substances | Absent |
| Arsenic | Not more than 3 mg/kg (expressed on dry weight basis) |
| Selenium | Not more than 30 mg/kg (expressed on dry weight basis) |
| Lead | Not more than 1 mg/kg (expressed on dry weight basis) |
E 955 SUCRALOSE
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