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 | Ditartaric acid |
| Definition | Definition |
| Einecs | |
| Chemical name | Metatartaric acid |
| Chemical formula | C4H6O6 |
| Molecular weight | |
| Assay | Not less than 99,5 % |
| Description | Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel |
| Identification | Identification |
| Solubility | Very soluble in water and ethanol |
| Identification test | Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulphuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 °C, an intense violet coloration appears |
| Purity | Purity |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 354 CALCIUM TARTRATE
| Synonyms | L-Calcium tartrate |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate |
| Chemical formula | C4H4CaO6 · 2H2O |
| Molecular weight | 224,18 |
| Assay | Not less than 98,0 % |
| Description | Fine crystalline powder with a white or off-white colour |
| Identification | Identification |
| Solubility | Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids |
| Specific rotation | [α]D 20 + 7,0° to + 7,4° (0,1 % in a 1N HCl solution) |
| pH | Between 6,0 and 9,0 (5 % slurry) |
| Purity | Purity |
| Sulphates | Not more than 1 g/kg (as H2SO4) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 355 ADIPIC ACID
| Synonyms | |
| Definition | Definition |
| Einecs | 204-673-3 |
| Chemical name | Hexanedioic acid; 1,4-butanedicarboxylic acid |
| Chemical formula | C6H10O4 |
| Molecular weight | 146,14 |
| Assay | Content not less than 99,6 % |
| Description | White odourless crystals or crystalline powder |
| Identification | Identification |
| Melting range | 151,5-154,0 °C |
| Solubility | Slightly soluble in water. Freely soluble in ethanol |
| Purity | Purity |
| Water | Not more than 0,2 % (Karl Fischer method) |
| Sulphated ash | Not more than 20 mg/kg |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 356 SODIUM ADIPATE
| Synonyms | |
| Definition | Definition |
| Einecs | 231-293-5 |
| Chemical name | Sodium adipate |
| Chemical formula | C6H8Na2O4 |
| Molecular weight | 190,11 |
| Assay | Content not less than 99,0 % (on anhydrous basis) |
| Description | White odourless crystals or crystalline powder |
| Identification | Identification |
| Melting range | 151-152 °C (for adipic acid) |
| Solubility | Approximately 50 g/100 ml water (20 °C) |
| Test for sodium | Passes test |
| Purity | Purity |
| Water content | Not more than 3 % (Karl Fischer) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 357 POTASSIUM ADIPATE
| Synonyms | |
| Definition | Definition |
| Einecs | 242-838-1 |
| Chemical name | Potassium adipate |
| Chemical formula | C6H8K2O4 |
| Molecular weight | 222,32 |
| Assay | Content not less than 99,0 % (on anhydrous basis) |
| Description | White odourless crystals or crystalline powder |
| Identification | Identification |
| Melting range | 151-152 °C (for adipic acid) |
| Solubility | Approximately 60 g/100 ml water (20 °C) |
| Test for potassium | Passes test |
| Purity | Purity |
| Water | Not more than 3 % (Karl Fischer) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 363 SUCCINIC ACID
| Synonyms | |
| Definition | Definition |
| Einecs | 203-740-4 |
| Chemical name | Butanedioic acid |
| Chemical formula | C4H6O4 |
| Molecular weight | 118,09 |
| Assay | Content no less than 99,0 % |
| Description | Colourless or white, odourless crystals |
| Identification | Identification |
| Melting range | 185,0-190,0 °C |
| Purity | Purity |
| Residue on ignition | Not more than 0,025 % (800 °C, 15 min) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 380 TRIAMMONIUM CITRATE
| Synonyms | Tribasic ammonium citrate |
| Definition | Definition |
| Einecs | 222-394-5 |
| Chemical name | Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid |
| Chemical formula | C6H17N3O7 |
| Molecular weight | 243,22 |
| Assay | Content not less than 97,0 % |
| Description | White to off-white crystals or powder |
| Identification | Identification |
| Test for ammonium | Passes test |
| Test for citrate | Passes test |
| Solubility | Freely soluble in water |
| Purity | Purity |
| Oxalate | Not more than 0,04 % (as oxalic acid) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
| Synonyms | Calcium disodium EDTA; Calcium disodium edetate |
| Definition | Definition |
| Einecs | 200-529-9 |
| Chemical name | N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium; Calcium disodium ethylenediaminetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate |
| Chemical formula | C10H12O8CaN2Na2·2H2O |
| Molecular weight | 410,31 |
| Assay | Content not less than 97 % on the anhydrous basis |
| Description | White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic |
| Identification | Identification |
| Test for sodium | Passes test |
| Test for calcium | Passes test |
| Chelating activity to metal ions | Positive |
| pH | Between 6,5 and 7,5 (1 % solution) |
| Purity | Purity |
| Water content | 5 to 13 % (Karl Fischer method) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Mercury | Not more than 1 mg/kg |
E 392 EXTRACTS OF ROSEMARY
| Synonyms | Extract of rosemary leaf (antioxidant) |
| Definition | Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification. |
| Einecs | 283-291-9 |
| Chemical name | Rosemary extract (Rosmarinus officinalis) |
| Description | Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised. |
| Identification | Identification |
| Reference antioxidative compounds: phenolic diterpenes | Carnosic acid (C20H28O4) and Carnosol (C20H26O4) (which comprise not less than 90 % of the total phenolic diterpenes) |
| Reference key volatiles | Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone |
| Density | > 0,25 g/ml |
| Solubility | Insoluble in water |
| Purity | Purity |
| Loss of drying | < 5 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
1 — Extracts of rosemary produced from dried rosemary leaves by acetone extraction.
| Description | Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid. |
| Identification | Identification |
| Content of reference antioxidative compounds | ≥ 10 % w/w, expressed as the total of carnosic acid and carnosol |
| Antioxidant/Volatiles — Ratio | (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles) ( as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’) |
| Purity | Purity |
| Residual solvents | Acetone: Not more than 500 mg/kg |
2 — Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide.
| Description | Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer. |
| Identification | Identification |
| Content of reference antioxidative compounds | ≥ 13 % w/w, expressed as the total of carnosic acid and carnosol |
| Antioxidant/Volatiles – Ratio | (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles) ( as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’) |
| Purity | Purity |
| Residual solvents | Ethanol: not more than 2 % |
3 — Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary.
| Description | Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried. |
| Identification | Identification |
| Content of reference antioxidative compounds | ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol |
| Antioxidant/Volatiles – Ratio | (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles) ( as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’) |
| Purity | Purity |
| Residual solvents | Ethanol: not more than 500 mg/kg |
4 — Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol.
| Description | Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried. |
| Identification | Identification |
| Content of reference antioxidative compounds | ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol |
| Antioxidant/Volatiles – Ratio | (Total % w/w of carnosic acid and carnosol) ≥ 15 (% w/w of reference key volatiles) ( as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’) |
| Purity | Purity |
| Residual solvents | Hexane: not more than 25 mg/kg Ethanol: not more than 500 mg/kg |
E 400 ALGINIC ACID
| Synonyms | |
| Definition | Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from strains of various species of brown seaweeds (Phaeophyceae) |
| Einecs | 232-680-1 |
| Chemical name | |
| Chemical formula | (C6H8O6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200) |
| Description | Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless |
| Identification | Identification |
| Solubility | Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate |
| Calcium chloride precipitation test | To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum. |
| Ammonium sulphate precipitation test | To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch. |
| Colour reaction | Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes a cherry-red colour develops that finally becomes deep purple. |
| pH | Between 2,0 and 3,5 (3 % suspension) |
| Purity | Purity |
| Loss on drying | Not more than 15 % (105 °C, 4 hours) |
| Sulphated ash | Not more than 8 % on the anhydrous basis |
| Sodium hydroxide (1 M solution) insoluble matter | Not more than 2 % on the anhydrous basis |
| Formaldehyde | 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 |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 401 SODIUM ALGINATE
| Synonyms | |
| Definition | Definition |
| Einecs | |
| Chemical name | Sodium salt of alginic acid |
| Chemical formula | (C6H7NaO6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222) |
| Description | Nearly odourless, white to yellowish fibrous or granular powder |
| Identification | Identification |
| Test for sodium | Passes test |
| Test for alginic acid | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 15 % (105 °C, 4 hours) |
| Water insoluble matter | Not more than 2 % on the anhydrous basis |
| Formaldehyde | 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 |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 402 POTASSIUM ALGINATE
| Synonyms | |
| Definition | Definition |
| Einecs | |
| Chemical name | Potassium salt of alginic acid |
| Chemical formula | (C6H7KO6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238) |
| Description | Nearly odourless, white to yellowish fibrous or granular powder |
| Identification | Identification |
| Test for potassium | Passes test |
| Test for alginic acid | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 15 % (105 °C, 4 hours) |
| Water insoluble matter | Not more than 2 % on the anhydrous basis |
| Formaldehyde | 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 |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 403 AMMONIUM ALGINATE
| Synonyms | |
| Definition | Definition |
| Einecs | |
| Chemical name | Ammonium salt of alginic acid |
| Chemical formula | (C6H11NO6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217) |
| Description | White to yellowish fibrous or granular powder |
| Identification | Identification |
| Test for ammonium | Passes test |
| Test for alginic acid | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 15 % (105 °C, 4 hours) |
| Sulphated ash | Not more than 7 % on the dried basis |
| Water insoluble matter | Not more than 2 % on the anhydrous basis |
| Formaldehyde | Not more than 50 mg/kg |
| 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 |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 404 CALCIUM ALGINATE
| Synonyms | Calcium salt of alginate |
| Definition | Definition |
| Einecs | |
| Chemical name | Calcium salt of alginic acid |
| Chemical formula | (C6H7Ca1/2O6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219) |
| Description | Nearly odourless, white to yellowish fibrous or granular powder |
| Identification | Identification |
| Test for calcium | Passes test |
| Test for alginic acid | Passes test |
| Purity | Purity |
| Loss on drying | Not more than 15,0 % (105 °C, 4 hours) |
| Formaldehyde | 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 |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 405 PROPANE-1,2-DIOL ALGINATE
| Synonyms | Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; Propylene glycol alginate |
| Definition | Definition |
| Einecs | |
| Chemical name | 1,2-Propanediol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule |
| Chemical formula | (C9H14O7)n (esterified) |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of carbon dioxide (CO2) |
| Description | Nearly odourless, white to yellowish brown fibrous or granular powder |
| Identification | Identification |
| Test for 1,2-propanediol | Passes test (after hydrolysis) |
| Test for alginic acid | Passes test (after hydrolysis) |
| Purity | Purity |
| Loss on drying | Not more than 20 % (105 °C, 4 hours) |
| Total propane-1,2-diol content | Not less than 15 % and not more than 45 % |
| Free propane-1,2-diol content | Not more than 15 % |
| Water insoluble matter | Not more than 2 % on the anhydrous basis |
| Formaldehyde | 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 |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 500 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 406 AGAR
| Synonyms | Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; Layor Carang |
| Definition | Agar is a hydrophilic colloidal polysaccharide consisting mainly of galactose units with a regular alternation of L and D isomeric forms. These hexoses are alternately linked with alpha-1,3 and beta-1,4 bonds in the copolymer. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain strains of marine algae of the families Gelidiaceae and Gracilariaceae and relevant red algae of the class Rhodophyceae |
| Einecs | 232-658-1 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | The threshold gel concentration should not be higher than 0,25 % |
| Description | Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, agar powder appears more transparent. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose |
| Identification | Identification |
| Solubility | Insoluble in cold water; soluble in boiling water |
| Purity | Purity |
| Loss on drying | Not more than 22 % (105 °C, 5 hours) |
| Ash | Not more than 6,5 % on the anhydrous basis determined at 550 °C |
| Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid) | Not more than 0,5 % determined at 550 °C on the anhydrous basis |
| Insoluble matter (after stirring for 10 minutes in hot water) | Not more than 1,0 % |
| Starch | Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced |
| Gelatin and other proteins | Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes |
| Water absorption | Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 300 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 5 g |
E 407 CARRAGEENAN
| Synonyms | Products of commerce are sold under different names such as: Irish moss gelose; Eucheuman (from Eucheuma spp.); Iridophycan (from Iridaea spp.); Hypnean (from Hypnea spp.); Furcellaran or Danish agar (from Furcellaria fastigiata); Carrageenan (from Chondrus and Gigartina spp.) |
| Definition | Carrageenan is obtained by extraction with water or dilute aqueous alkali of strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysacharide. These hexoses are alternately linked α-1,3 and β-1,4 in the copolymer. The prevalent polysaccharides in carrageenan are designated as kappa, iota, lambda depending on the number of sulphate by repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2. During the process, no organic precipitant shall be used other than methanol, ethanol and propan-2-ol. The wording carrageenan is reserved for the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present as an adventitious impurity up to a maximum of 5 mg/kg. |
| Einecs | 232-524-2 |
| Chemical name | Sulphate esters of polygalactose |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Yellowish to colourless, coarse to fine powder which is practically odourless |
| Identification | Identification |
| Test for galactose | Passes test |
| Test for anhydrogalactose | Passes test |
| Test for sulphate | Passes test |
| Solubility | Soluble in hot water; insoluble in alcohol for a 1,5 % dilution |
| Purity | Purity |
| Solvent residues | Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination |
| Viscosity | Not less than 5 mPa.s (1,5 % solution at 75 °C) |
| Loss on drying | Not more than 12 % (105 °C, 4 hours) |
| Sulphates | Not less than 15 % and not more than 40 % on the dried basis (as SO4) |
| Ash | Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C |
| Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) |
| Acid-insoluble matter | Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid) |
| Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) | Not more than 5 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 2 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 300 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 407a PROCESSED EUCHEUMA SEAWEED
| Synonyms | PES (acronym for processed eucheuma seaweed). The PES obtained from Euchema cottonii is generally called kappa PES and the PES from Euchema spinosum iota PES. |
| Definition | Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment at high temperature of the strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) followed by fresh water washing to remove impurities and drying to obtain the product. Further purification may be achieved by washing with an alcohol. The alcohols authorised are restricted to methanol, ethanol or propan-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wording processed eucheuma seaweed is reserved to the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present up to a maximum of 5 mg/kg. |
| Description | Tan to yellowish, coarse to fine powder which is practically odourless |
| Identification | Identification |
| Test for galactose | Passes test |
| Test for anhydrogalactose | Passes test |
| Test for sulphate | Passes test |
| Solubility | Forms cloudy viscous suspensions in water. Insoluble in ethanol for a 1,5 % solution. |
| Purity | Purity |
| Solvent residues | Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination |
| Viscosity | Not less than 5 mPa.s (1,5 % solution at 75 °C) |
| Loss on drying | Not more than 12 % (105 °C, 4 hours) |
| Sulphate | Not less than 15 % and not more than 40 % on the dried basis (as SO4) |
| Ash | Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C |
| Acid-insoluble ash | Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid) |
| Acid-insoluble matter | Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid) |
| Low molecular weight carrageenan (Molecular weight fraction below 50 kDa) | Not more than 5 % |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 2 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colonies per gram |
| Yeast and moulds | Not more than 300 colonies per gram |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 10 g |
E 410 LOCUST BEAN GUM
| Synonyms | Carob bean gum; Algaroba gum |
| Definition | Locust bean gum is the ground endosperm of the seeds of the strainsof carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). The seeds are dehusked by treating the kernels with dilute sulfuric acid or with thermal mechanical treatments, elimination of the germ, followed by milling and screening of the endosperm to obtain native locust bean gum. Locust bean gum consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan. |
| Einecs | 232-541-5 |
| CAS number | 9000-40-2 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | 50 000 –3 000 000 |
| Assay | Galactomannan content not less than 75 % |
| Description | White to yellowish-white, nearly odourless powder |
| Identification | |
| Test for galactose | Passes test |
| Test for mannose | Passes test |
| Microscopic examination | Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed than in guar gum. Guar gum shows close groups of round to pear-shaped cells. Their contents are yellow to brown |
| Solubility | Fully dispersible in hot water, insoluble in ethanol |
| Purity | |
| Loss on drying | Not more than 15 % (105 °C, 5 hours) |
| Ash | Not more than 1,2 % determined at 800 °C |
| Protein (N × 6,25) | Not more than 7 % |
| Acid-insoluble matter | Not more than 4 % |
| Starch | Not detectable by the following method: to a 1 in 10 dispersion of the sample add a few drops of iodine solution. No blue colour is produced. |
| Arsenic | Not more than 0,1 mg/kg |
| Lead | Not more than 0,4 mg/kg |
| Mercury | Not more than 0,1 mg/kg |
| Cadmium | Not more than 0,1 mg/kg |
| Ethanol and propan-2-ol | Not more than 1 %, single or in combination |
| Microbiological criteria | |
| Total plate count | Not more than 5 000 cfu/g |
| Yeast and moulds | Not more than 500 cfu/g |
| Enterobacteriaceae | Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Escherichia coli | Absent in 1 g |
| Salmonella spp. | Absent in 25 g |
| Cronobacter spp. (Enterobacter sakazakii) | Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age) |
E 412 GUAR GUM
| Synonyms | Gum cyamopsis; Guar flour |
| Definition | Guar gum is the ground endosperm of the seeds of strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). The germ and endosperm are separated via milling and sieving. The hull is removed via treatment with moist or dry, hot air and sieving. Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjustment. |
| Einecs | 232-536-0 |
| CAS number | 9000-30-0 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | 50 000 –8 000 000 |
| Assay | Galactomannan content not less than 75 % |
| Description | A white to yellowish-white, nearly odourless powder |
| Identification | |
| Test for galactose | Passes test |
| Test for mannose | Passes test |
| Solubility | Dispersible in cold water |
| Purity | |
| Loss on drying | Not more than 15 % (105 °C, 5 hours) |
| Ash | Not more than 5,5 % determined at 800 °C |
| Acid-insoluble matter | Not more than 7 % |
| Protein | Not more than 10 % (factor N × 6,25) (Kjeldahl method) |
| Starch | Not detectable by the following method: to a 1 in 10 dispersion of the sample add a few drops of iodine solution. No blue colour is produced. |
| Organic peroxides | Not more than 0,7 meq active oxygen/kg sample |
| Furfural | Not more than 1 mg/kg |
| Pentachlorophenol | Not more than 0,01 mg/kg |
| Arsenic | Not more than 0,1 mg/kg |
| Lead | Not more than 0,2 mg/kg |
| Mercury | Not more than 0,1 mg/kg |
| Cadmium | Not more than 0,1 mg/kg |
| Microbiological criteria | |
| Total plate count | Not more than 5 000 cfu/g |
| Yeast and moulds | Not more than 500 cfu/g |
| Enterobacteriaceae | Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Escherichia coli | Absent in 1 g |
| Salmonella spp. | Absent in 25 g |
E 413 TRAGACANTH
| Synonyms | Tragacanth gum; Tragant |
| Definition | Tragacanth is a dried exudation obtained from the stems and branches of strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present |
| Einecs | 232-252-5 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | Approximately 800 000 |
| Assay | |
| Description | Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour |
| Identification | Identification |
| Solubility | 1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol |
| Purity | Purity |
| Test for Karaya gum | Negative. Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops |
| Loss on drying | Not more than 16 % (105 °C, 5 hours) |
| Total ash | Not more than 4 % |
| Acid insoluble ash | Not more than 0,5 % |
| Acid insoluble matter | 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 |
| Microbiological criteria | Microbiological criteria |
| Salmonella spp. | Absent in 10 g |
| Escherichia coli | Absent in 5 g |
E 414 GUM ARABIC (ACACIA GUM)
| Synonyms | |
| Definition | Acacia gum is a dried exudation obtained from the stems and branches of strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid. |
| Einecs | 232-519-5 |
| CAS number | 9000-01-5 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | Approximately 350 000 |
| Assay | |
| Description | Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material. |
| Identification | |
| Solubility | 1 g dissolves in 2 ml of cold water forming a dispersion which flows readily and is acid to litmus, insoluble in ethanol. |
| Purity | |
| Loss on drying | Not more than 17 % (105 °C, 5 hours) for granular and not more than 10 % (105 °C, 4 hours) for spray-dried material |
| Total ash | Not more than 4 % |
| Acid insoluble ash | Not more than 0,5 % |
| Acid insoluble matter | Not more than 1 % |
| Starch or dextrin | Boil a 1 in 50 dispersion of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced. |
| Tannin | To 10 ml of a 1 in 50 dispersion add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed. |
| Arsenic | Not more than 0,1 mg/kg |
| Lead | Not more than 0,05 mg/kg |
| Mercury | Not more than 0,05 mg/kg |
| Cadmium | Not more than 0,05 mg/kg |
| Aluminium | Not more than 100 mg/kg (only if added to foods for infants and young children) Not more than 200 mg/kg (for all uses except for foods intended for infants and young children) |
| Hydrolysis products | Mannose, xylose and galacturonic acid are absent (determined by chromatography). |
| Proteins | Not more than 3,5 % Oxidases and peroxidases occurring in acacia gum naturally or as a result of processing should be inactivated during the manufacturing process of acacia gum used in foods for infants and young children. |
| Microbiological criteria | |
| Total plate count | Not more than 10 000 cfu/g |
| Yeast and moulds | Not more than 10 000 cfu/g |
| Salmonella spp. | Absent in 25 g |
| Enterobacteriaceae | Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Escherichia coli | Absent in 5 g |
| Cronobacter spp. (Enterobacter sakazakii) | Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age) |
E 415 XANTHAN GUM
| Synonyms | |
| Definition | Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with strains of Xanthomonas campestris, which are unequivocally identified and meet the criteria for qualification for QPS status (i.e. absence of acquired antimicrobial resistance genes), purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid, pyruvic acid and acetic acid, and is prepared as the sodium, potassium or calcium salt. Its dispersions in water are neutral. The final product must not show any residual enzyme activity. |
| Einecs | 234-394-2 |
| CAS number | 11138-66-2 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | Approximately 1 000 000 |
| Assay | Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum |
| Description | Cream-coloured powder |
| Identification | |
| Solubility | Dispersible in water. Insoluble in ethanol. |
| Purity | |
| Loss on drying | Not more than 15 % (105 °C, 2,5 hours) |
| Total ash | Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours |
| Pyruvic acid | Not less than 1,5 % |
| Nitrogen | Not more than 1,5 % (Kjeldahl method) |
| Ethanol and propan-2-ol | Not more than 500 mg/kg singly or in combination |
| Arsenic | Not more than 0,1 mg/kg |
| Lead | Not more than 0,5 mg/kg |
| Mercury | Not more than 0,05 mg/kg |
| Cadmium | Not more than 0,3 mg/kg |
| Microbiological criteria | |
| Total plate count | Not more than 5 000 cfu/g |
| Yeast and moulds | Not more than 300 cfu/g |
| Enterobacteriaceae | Absent in 10 g (only if added to dried infant formulae, dried foods for special medical purposes intended for infants below 6 months of age and dried follow-on formulae) |
| Escherichia coli | Absent in 5 g |
| Salmonella spp. | Absent in 25 g |
| Cronobacter spp. (Enterobacter sakazakii) | Absent in 10 g (only if added to dried infant formulae and dried foods for special medical purposes intended for infants below 6 months of age) |
| Xanthomonas campestris | Viable cells absent in 1 g |
E 416 KARAYA-GUM
| Synonyms | Katilo; Kadaya; Gum sterculia; Sterculia; Karaya, gum karaya; Kullo; Kuterra |
| Definition | Karaya gum is a dried exudation from the stems and branches of strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid |
| Einecs | 232-539-4 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid |
| Identification | Identification |
| Solubility | Insoluble in ethanol |
| Swelling in ethanol solution | Karaya gum swells in 60 % ethanol distinguishing it from other gums |
| Purity | Purity |
| Loss on drying | Not more than 20 % (105 °C, 5 hours) |
| Total ash | Not more than 8 % |
| Acid insoluble ash | Not more than 1 % |
| Acid insoluble matter | Not more than 3 % |
| Volatile acid | Not less than 10 % (as acetic acid) |
| Starch | Not detectable |
| 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 |
| Microbiological criteria | Microbiological criteria |
| Salmonella spp. | Absent in 10 g |
| Escherichia coli | Absent in 5 g |
E 417 TARA GUM
| Definition | Tara gum is obtained by grinding the endosperm of the seeds of strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1) |
| Einecs | 254-409-6 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | |
| Description | A white to white-yellow odourless powder |
| Identification | Identification |
| Solubility | Soluble in water, insoluble in ethanol |
| Gel formation | To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed |
| Purity | Purity |
| Loss on drying | Not more than 15 % |
| Ash | Not more than 1,5 % |
| Acid insoluble matter | Not more than 2 % |
| Protein | Not more than 3,5 % (factor N x 5,7) |
| Starch | Not detectable |
| 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 |
E 418 GELLAN GUM
| Synonyms | |
| Definition | Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by strains of Pseudomonas elodea, purified by recovery with propan-2-ol or ethanol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt |
| Einecs | 275-117-5 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | Approximately 500 000 |
| Assay | Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2 |
| Description | An off-white powder |
| Identification | Identification |
| Solubility | Soluble in water, forming a viscous solution. Insoluble in ethanol |
| Purity | Purity |
| Loss on drying | Not more than 15 % after drying (105 °C, 2,5 hours) |
| Nitrogen | Not more than 3 % |
| Propan-2-ol | Not more than 750 mg/kg |
| 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 |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 10 000 colonies per gram |
| Yeast and moulds | Not more than 400 colonies per gram |
| Escherichia coli | Negative in 5 g |
| Salmonella spp. | Negative in 10 g |
E 420 (i) SORBITOL
| Synonyms | D-glucitol; D-sorbitol |
| Definition | Sorbitol is obtained by hydrogenation of D-glucose. It is mainly composed of D-sorbitol. According to the level of D-glucose, the part of the products which is not D-sorbitol is composed of related substances such as mannitol, iditol, maltitol. |
| Einecs | 200-061-5 |
| Chemical name | D-glucitol |
| Chemical formula | C6H14O6 |
| Molecular weight | 182,2 |
| Assay | Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer). |
| Description | White hygroscopic powder, crystalline powder, flakes or granules. |
| Appearance of the aqueous solution: | The solution is clear. |
| Identification | Identification |
| Solubility | Very soluble in water, slightly soluble in ethanol |
| Melting range | 88 to 102 °C |
| Sorbitol monobenzylidene derivative | To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C |
| Purity | Purity |
| Water content | Not more than 1,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose on dry weight basis) |
| Total sugars | Not more than 1 % (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 420 (ii) SORBITOL SYRUP
| Synonyms | D-glucitol syrup |
| Definition | Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides. The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer) |
| Einecs | 270-337-8 |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis |
| Description | Clear and colourless aqueous solution |
| Identification | Identification |
| Solubility | Miscible with water, with glycerol, and with propane-1,2-diol |
| Sorbitol monobenzylidene derivative | To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C |
| Purity | Purity |
| Water content | Not more than 31 % (Karl Fischer Method) |
| Conductivity | Not more than 10 μS/cm (on the product as such) at temperature 20 °C |
| 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 421 (i) MANNITOL BY HYDROGENATION
(i) MANNITOL
| Synonyms | D-mannitol |
| Definition | Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose. The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each. |
| Einecs | 200-711-8 |
| Chemical name | D-mannitol |
| Chemical formula | C6H14O6 |
| Molecular weight | 182,2 |
| Assay | Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis |
| Description | White, odourless, crystalline powder |
| Identification | Identification |
| Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether |
| Melting range | Between 164 and 169 °C |
| Infrared absorption spectrometry | Comparison with a reference standard e.g. EP or USP |
| Specific rotation | [α]D 20 + 23° to + 25° (borate solution) |
| pH | Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH |
| Purity | Purity |
| Water content | Not more than 0,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose) |
| Total sugars | Not more than 1 % (expressed as glucose) |
| Nickel | Not more than 2 mg/kg |
| Lead | Not more than 1 mg/kg |
(ii) MANNITOL MANUFACTURED BY FERMENTATION
| Synonyms | D-mannitol |
| Definition | Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt. |
| Einecs | 200-711-8 |
| Chemical name | D-mannitol |
| Chemical formula | C6H14O6 |
| Molecular weight | 182,2 |
| Assay | Not less than 99 % on the dried basis |
| Description | White, odourless crystalline powder |
| Identification | Identification |
| Solubility | Soluble in water, very slightly soluble in ethanol, practically insoluble in ether |
| Melting range | Between 164 and 169 °C |
| Infrared absorption spectrometry | Comparison with a reference standard e.g. EP or USP |
| Specific rotation | [α]D 20 + 23° to + 25° (borate solution) |
| pH | Between 5 and 8 Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH |
| Purity | Purity |
| Arabitol | Not more than 0,3 % |
| Water content | Not more than 0,5 % (Karl Fischer Method) |
| Conductivity | Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C |
| Reducing sugars | Not more than 0,3 % (expressed as glucose) |
| Total sugars | Not more than 1 % (expressed as glucose) |
| Lead | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Aerobic mesophilic bacteria | Not more than 1 000 colonies per gram |
| Coliforms | Absent in 10 g |
| Salmonella spp. | Absent in 25 g |
| Escherichia coli | Absent in 10 g |
| Staphylococcus aureus | Absent in 10 g |
| Pseudomonas aeruginosa | Absent in 10 g |
| Moulds | Not more than 100 colonies per gram |
| Yeasts | Not more than 100 colonies per gram |
E 422 GLYCEROL
| Synonyms | Glycerin; Glycerine |
| Definition | Glycerol is obtained only from vegetable oils and fats, either directly or from the crude glycerol obtained as a by-product of biodiesel production and undergoes purification processes that involve distillation, and other clean up steps to obtain refined glycerol. |
| Einecs | 200-289-5 |
| Chemical name | 1,2,3-propanetriol; Glycerol; Trihydroxypropane |
| Chemical formula | C3H8O3 |
| Molecular weight | 92,10 |
| Assay | Content not less than 98 % of glycerol on the anhydrous basis |
| Description | Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable |
| Identification | |
| Specific gravity (25 °C/25 °C) | Not less than 1,257 |
| Refractive index | [n]D 20 between 1,471 and 1,474 |
| Purity | |
| Water content | Not more than 5 % (Karl Fischer method) |
| Sulphated ash | Not more than 0,01 % determined at 800 ± 25 °C |
| Butanetriols | Not more than 0,2 % |
| Acrolein | Not more than 3 mg/kg |
| Fatty acids and esters | Not more than 0,1 % calculated as butyric acid |
| Chlorinated compounds | Not more than 30 mg/kg (as chlorine) |
| 3-Monochloropropane-1,2-diol (3- MCPD) | Not more than 0,1 mg/kg |
| Arsenic | Not more than 0,1 mg/kg |
| Lead | Not more than 0,1 mg/kg |
| Mercury | Not more than 0,1 mg/kg |
| Cadmium | Not more than 0,1 mg/kg |
E 423 OCTENYL SUCCINIC ACID MODIFIED GUM ARABIC
| Synonyms | Gum arabic hydrogen octenylbutandioate; Gum arabic hydrogen octenylsuccinate; OSA modified gum arabic; OSA modified gum acacia |
| Definition | Octenyl succinic acid modified gum arabic is produced by esterifying gum arabic (Acacia seyal), or gum arabic (Acacia senegal) in aqueous solution with not more than 3 % of octenyl succinic acid anhydride. It is subsequently spray dried. |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Weight Average Molecular Weight | Fraction (i): 3,105 g/mol Fraction (ii) 1,106 g/mol |
| Assay | |
| Description | Off-white to light tan, free flowing powder |
| Identification | Identification |
| Viscosity of a 5 % solution at 25 °C | Not more than 30 mPa.s. |
| Precipitation reaction | Forms flocculent precipitate in lead sub-acetate solution (TS) |
| Solubility | Freely soluble in water; insoluble in ethanol |
| pH for a 5 % aqueous solution | 3,5 to 6,5 |
| Purity | Purity |
| Loss on drying | Not more than 15 % (105 °C, 5 h) |
| Degree of esterification | Not more than 0,6 % |
| Total ash | Not more than 10 % (530 °C) |
| Acid-insoluble ash | Not more than 0,5 % |
| Water insoluble matter | Not more than 1,0 % |
| Test for starch or dextrine | Boil a 1 in 50 aqueous solution of the sample, add about 0,1 ml iodine TS. No bluish or reddish colour should be produced. |
| Test for tannin-bearing gums | To 10 ml of a 1 in 50 aqueous solution of the sample add about 0,1 ml ferric chloride TS. No blackish coloration or blackish precipitate should be formed. |
| Residual octenyl succinic acid | Not more than 0,3 % |
| Lead | Not more than 2 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Salmonella sp. | Absent in 25 g |
| Escherichia coli | Absent in 1 g |
E 425 (i) KONJAC GUM
| Synonyms | |
| Definition | Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000 |
| Assay | Not less than 75 % carbohydrate |
| Description | A white to cream to light tan powder |
| Identification | Identification |
| Solubility | Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0 |
| Gel formation | Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms |
| Formation of heat-stable gel | Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed |
| Purity | Purity |
| Loss on drying | Not more than 12 % (105 °C, 5 hours) |
| Starch | Not more than 3 % |
| Protein | Not more than 3 % (factor N × 5,7) |
| Viscosity (1 % solution) | Not less than 3 kgm– 1s– 1 at 25 °C |
| Ether-soluble material | Not more than 0,1 % |
| Total ash | Not more than 5,0 % (800 °C, 3 to 4 hours) |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 2 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Salmonella spp. | Absent in 12,5 g |
| Escherichia coli | Absent in 5 g |
E 425 (ii) KONJAC GLUCOMANNAN
| Synonyms | |
| Definition | Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | 500 000 to 2 000 000 |
| Assay | Total dietary fibre: not less than 95 % on a dry weight basis |
| Description | White to slightly brownish fine particle size, free flowing and odourless powder |
| Identification | Identification |
| Solubility | Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation |
| Formation of heat-stable gel | Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed |
| Purity | Purity |
| Loss on drying | Not more than 8 % (105 °C, 3 hours) |
| Starch | Not more than 1 % |
| Viscosity (1 % solution) | Not less than 20 kgm– 1s– 1 at 25 °C |
| Protein | Not more than 1,5 % (N × 5,7) Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample |
| Ether-soluble material | Not more than 0,5 % |
| Sulphite (as SO2) | Not more than 4 mg/kg |
| Chloride | Not more than 0,02 % |
| 50 % Alcohol-soluble material | Not more than 2,0 % |
| Total ash | Not more than 2,0 % (800 °C, 3 to 4 hours) |
| Lead | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Salmonella spp. | Absent in 12,5 g |
| Escherichia coli | Absent in 5 g |
E 426 SOYBEAN HEMICELLULOSE
| Synonyms | |
| Definition | Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol |
| Einecs | |
| Chemical name | Water soluble soybean polysaccharides; Water soluble soybean fibre |
| Chemical formula | |
| Molecular weight | |
| Assay | Not less than 74 % carbohydrate |
| Description | Free flowing white or yellowish white powder |
| Identification | Identification |
| Solubility | Soluble in hot and cold water without gel formation |
| pH | 5,5 ± 1,5 (1% solution) |
| Purity | Purity |
| Loss on drying | Not more than 7 % (105 °C, 4 hours) |
| Protein | Not more than 14 % |
| Viscosity | Not more than 200 mPa.s (10 % solution) |
| Total ash | Not more than 9,5 % (600 °C, 4 hours) |
| Arsenic | Not more than 2 mg/kg |
| Ethanol | Not more than 2% |
| Lead | Not more than 5 mg/kg |
| Mercury | Not more than 1 mg/kg |
| Cadmium | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 3 000 colonies per gram |
| Yeast and moulds | Not more than 100 colonies per gram |
| Escherichia coli | Absent in 10 g |
E 427 CASSIA GUM
| Synonyms | |
| Definition | Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1. In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol. |
| Assay | Not less than 75 % of Galactomannan |
| Description | Pale yellow to off-white, odourless powder |
| Identification | Identification |
| Solubility | Insoluble in ethanol. Disperses well in cold water forming a colloidal solution. |
| Gel formation with borate | To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed. |
| Gel formation with xanthan gum | Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h. A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner. |
| Viscosity | Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000 -300 000 Da |
| Purity | Purity |
| Acid insoluble matter | Not more than 2,0 % |
| pH | 5,5-8 (1 % aqueous solution) |
| Crude fat | Not more than 1 % |
| Protein | Not more than 7 % |
| Total ash | Not more than 1,2 % |
| Loss on drying | Not more than 12 % (5h, 105 °C) |
| Total anthraquinones | Not more than 0,5 mg/kg(detection limit) |
| Solvent residues | Not more than 750 mg/kg Propan-2-ol |
| Lead | Not more than 1 mg/kg |
| Microbiological criteria | Microbiological criteria |
| Total plate count | Not more than 5 000 colony forming units per gram |
| Yeast and moulds | Not more than 100 colony forming units per gram |
| Salmonella spp. | Absent in 25 g |
| Escherichia coli | Absent in 1 g |
E 431 POLYOXYETHYLENE (40) STEARATE
| Synonyms | Polyoxyl (40) stearate; Polyoxyethylene (40) monostearate |
| Definition | A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Content not less than 97,5 % on the anhydrous basis |
| Description | Cream-coloured flakes or waxy solid at 25 °C with a faint odour |
| Identification | Identification |
| Solubility | Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil |
| Congealing range | 39-44 °C |
| Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol |
| Purity | Purity |
| Water content | Not more than 3 % (Karl Fischer method) |
| Acid value | Not more than 1 |
| Saponification value | Not less than 25 and not more than 35 |
| Hydroxyl value | Not less than 27 and not more than 40 |
| 1,4-Dioxane | Not more than 5 mg/kg |
| ————— | ————— |
| Ethylene glycols (mono- and di-) | Not more than 0,25 % |
| 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 |
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
| Synonyms | Polysorbate 20; Polyoxyethylene (20) sorbitan monolaurate |
| Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides |
| Einecs | |
| Chemical name | |
| Chemical formula | |
| Molecular weight | |
| Assay | Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis |
| Description | A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour |
| Identification | Identification |
| Solubility | Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether |
| Infrared absorption spectrum | Characteristic of a partial fatty acid ester of a polyoxyethylated polyol |
| Purity | Purity |
| Water content | Not more than 3 % (Karl Fischer method) |
| Acid value | Not more than 2 |
| Saponification value | Not less than 40 and not more than 50 |
| Hydroxyl value | Not less than 96 and not more than 108 |
| 1,4-dioxane | Not more than 5 mg/kg |
| ————— | ————— |
| Ethylene glycols (mono- and di-) | Not more than 0,25 % |
| 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 |
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
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