Commission Directive 98/86/EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
9. 12. 98 EN Official Journal of the European Communities L 334/1 I (Acts whose publication is obligatory) COMMISSION DIRECTIVE 98/86/EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), as amended by European Parliament and Council Directive 94/34/EC (2) and in particular Article 3(3)(a) thereof; After consulting the Scientific Committee for Food; Whereas, it is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours last amended by Directive and 98/72/EC (4); sweeteners (3), as Whereas, it is necessary to replace the purity criteria set out in Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity for emulsifiers, stabilisers, thickeners and gelling agents which may be used in foodstuffs intended for human consumption (5), as last amended by Commission Directive 92/4/EEC (6); (1) OJ L 40, 11. 2. 1989, p. 27. (2) OJ L 237, 10. 9. 1994, p. 1. (3) OJ L 61, 18. 3. 1995, p. 1. (4) OJ L 295, 4. 11. 1998, p. 18. (5) OJ L 223, 14. 8. 1978, p. 7. (6) OJ L 55, 29. 2. 1992, p. 96. Whereas Commission Directive 96/77/EC of 2 December laying down specific purity criteria on food 1996 additives other than colours and sweeteners (7) set out a first list of purity criteria for a number of food additives; whereas this list should now be complemented with the newly established purity criteria for other additives; it is necessary to take Whereas into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); included Whereas food additives, if prepared by production methods or starting materials significantly different from in the evaluation of the Scientific those Committee those if different mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria; for Food, or from Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 Directive 96/77/EC shall be amended as follows: (7) OJ L 339, 30. 12. 1996, p. 1. L 334/2 EN Official Journal of the European Communities 9. 12. 98 1. Article 2 is replaced by the following: ‘Article 2 Products put on the market or labelled before 1 July 2. 1999 which do not comply with this Directive may be marketed until stocks are exhausted. The purity criteria referred to in Article 1 replace the in Directives 65/66/EEC, purity criteria set out 78/663/EEC and 78/664/EEC. ’ Article 3 2. In the Annex, the text of the Annex to this Directive shall be added. This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 2 Article 4 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1999. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. This Directive is addressed to the Member States. Done at Brussels, 11 November 1998. For the Commission Martin BANGEMANN Member of the Commission 9. 12. 98 EN Official Journal of the European Communities L 334/3 ANNEX ‘Ethylene oxide may not be used for sterilising purposes in food additives E 400 ALGINIC ACID Definition Linear glycuronoglycan consisting mainly of â-(1-4) linked D-mannuronic and Æ-(1-4) form. Hydrophilic colloidal linked L-guluronic acid units carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae) in pyranose ring Einecs Chemical formula 232-680-1 (C6H8O6)n Molecular weight 10 000—600 000 (typical average) Assay Description Identification A. Solubility B. Calcium chloride precipitation test C. Ammonium sulphate precipitation test D. Colour reaction Purity 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) Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate 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 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 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 of a 3 % suspension Between 2,0 and 3,5 Loss on drying Sulphated ash Not more than 15 % (105 °C, 4 hours) Not more than 8 % on the anhydrous basis Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble matter Arsenic Not more than 3 mg/kg L 334/4 EN Official Journal of the European Communities 9. 12. 98 Lead Mercury Cadmium Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 500 colonies per gram E. coli Salmonella spp. Negative in 5 g Negative in 10 g E 401 SODIUM ALGINATE Definition Chemical name Chemical formula Molecular weight Assay Sodium salt of alginic acid (C6H7NaO6)n 10 000-600 000 (typical average) 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 A. Positive test for sodium and alginic acid Purity Loss on drying Not more than 15 % (105 °C, 4 hours) Water-insoluble matter Not more than 2 % on the anhydrous basis Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 500 colonies per gram E. coli Salmonella spp. Negative in 5 g Negative in 10 g 9. 12. 98 EN Official Journal of the European Communities L 334/5 E 402 POTASSIUM ALGINATE Definition Chemical name Chemical formula Molecular weight Assay Potassium salt of alginic acid (C6H7KO6)n 10 000-600 000 (typical average) 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 A. Positive test for potassium and for alginic acid Purity Loss on drying Not more than 15 % (105 °C, 4 hours) Water-insoluble matter Not more than 2 % on the anhydrous basis Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 500 colonies per gram E. coli Salmonella spp. Negative in 5 g Negative in 10 g E 403 AMMONIUM ALGINATE Definition Chemical name Chemical formula Molecular weight Assay Ammonium salt of alginic acid (C6H11NO6)n 10 000-600 000 (typical average) 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 L 334/6 EN Official Journal of the European Communities 9. 12. 98 Identification A. Positive test for ammonium and alginic acid Purity Loss on drying Sulphated ash Not more than 15 % (105 °C, 4 hours) Not more than 7 % on the dried basis Water-insoluble matter Not more than 2 % on the anhydrous basis Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 500 colonies per gram E. coli Salmonella spp. Negative in 5 g Negative in 10 g E 404 CALCIUM ALGINATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Calcium salt of alginate Calcium salt of alginic acid (C6H7Ca1/2O6)n 10 000-600 000 (typical average) 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 A. Positive test for calcium and alginic acid Purity Loss on drying Arsenic Not more than 15,0 % (105 °C, 4 hours) Not more than 3 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/7 Lead Mercury Cadmium Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Yeast and moulds E. coli Salmonella spp. Not more than 5 000 colonies per gram Not more than 500 colonies per gram Negative in 5 g Negative in 10 g E 405 PROPANE-1,2-DIOL ALGINATE Synonyms Definition Chemical name Hydroxypropyl alginate 1,2-propanediol ester of alginic acid Propylene glycol alginate Propane-1,2-diol 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 CO2 of carbon dioxide Description Nearly odourless, white to yellowish brown fibrous or granular powder Identification A. Positive test for 1,2-propanediol and alginic acid after hydrolysis 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 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg L 334/8 EN Official Journal of the European Communities 9. 12. 98 Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 500 colonies per gram E. coli Negative in 5 g Salmonella spp. Negative in 10 g E 406 AGAR Synonyms Definition Chemical name Einecs Assay Description Identification Gelose Japan agar Bengal, Ceylon, Chinese or Japanese isinglass Layor Carang Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. 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 natural strains of marine algae of the families Gelidiaceae und Sphaerococcaceae and related red algae of the class Rhodophyceae 232-658-1 The threshold gel concentration should not be higher than 0,25 % 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, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. 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 A. Solubility Insoluble in cold water; soluble in boiling water 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 (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 9. 12. 98 EN Official Journal of the European Communities L 334/9 Gelatin and other proteins Water absorption 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 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 Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 407 CARRAGEENAN Synonyms Definition Products of commerce are sold under different names such as: — Irish moss gelose — Eucheuman (from Eucheuma spp. ) — Iridophycan (from Irdidaea spp. ) — Hypnean (from Hypnea spp. ) — Furcellaran or Danish agar (from Furcellaria fastigiata) — Carrageenan (from Chondrus and Gigartina spp. ) Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded Einecs 232-524-2 Description Yellowish to colourless, coarse to fine powder which is practically odourless Identification A. Positive tests for galactose, for anhydrogalactose and for sulphate Purity Methanol, ethanol propane-2-ol content Not more than 0,1 % singly or in combination Viscosity of a 1,5 % solution at 75 °C Not less than 5 mPa. s Loss on drying Not more than 12 % (105 °C, 4 hours) Sulphate Not less than 15 % and not more than 40 % on the anhydrous basis (as SO4) L 334/10 EN Official Journal of the European Communities 9. 12. 98 Ash Not less than 15 % and not more than 40 % determined on the anhydrous basis at 550 °C Acid-insoluble ash Not more than 1 % on the anhydrous basis (insoluble in 10 % hydrochloric acid) Acid-insoluble matter Not more than 2 % on the anhydrous basis (insoluble in 1 % v/v sulphuric acid) Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and moulds Not more than 300 colonies per gram E. coli Salmonella spp. Negative in 5 g Negative in 10 g E 407a PROCESSED EUCHEUMA SEAWEED Synonyms Definition PES (acronym for processed eucheuma seaweed) Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii und Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded Description Tan to yellowish, coarse to fine powder which is practically odourless Identification A. Positive tests for galactose, for anhydrogalactose and for sulphate B. Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanol Purity Methanol, ethanol, propane-2-ol content Not more than 0,1 % singly or in combination Viscosity of a 1,5 % solution at 75 °C Not less than 5 mPa. s Loss on drying Not more than 12 % (105 °C, 4 hours) 9. 12. 98 EN Official Journal of the European Communities L 334/11 Sulphate Ash Not less than 15 % and not more than 40 % on the dried basis (as SO4) Not less than 1 % 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) Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 5 000 colonies per gram Yeast and mould Not more than 300 colonies per gram E. coli Negative in 5 g Salmonella spp. Negative in 10 g E 410 LOCUST BEAN GUM Synonyms Definition Carob bean gum Algaroba gum Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L. ) Taub. (family Leguminosae). 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 Molecular weight 50 000—3 000 000 Einecs Assay 232-541-5 Galactomannan content not less than 75 % Description White to yellowish-white, nearly odourless powder Identification A. Positive tests for galactose mannose B. 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 in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown C. Solubility Soluble in hot water, insoluble in ethanol L 334/12 EN Official Journal of the European Communities 9. 12. 98 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 Arsenic Lead Mercury Cadmium 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 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Ethanol and propane-2-ol Not more than 1 %, single or in combination E 412 GUAR GUM Synonyms Definition Gum cyamopsis Guar flour Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L. ) Taub. (family Leguminosae). 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 232-536-0 Molecular weight 50 000—8 000 000 Assay Description Identification Galactomannan content not less than 75 % A white to yellowish-white, nearly odourless powder A. Positive tests for galactose and for mannose B. Solubility Purity Soluble in cold water Loss on drying Not more than 15 % (105 °C, 5 hours) Ash Not more than 1,5 % determined at 800 °C Acid-insoluble matter Not more than 7 % Protein (N × 6,25) Not more than 10 % 9. 12. 98 EN Official Journal of the European Communities L 334/13 Starch Arsenic Lead Mercury Cadmium 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) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 413 TRAGACANTH Synonyms Definition Tragacanth gum Tragant Tragacanth is a dried exudation obtained from the stems and branches of natural 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 Molecular weight Approximately 800 000 Einecs Description Identification A. Solubility Purity 232-252-5 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 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 Negative test for Karaya gum 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 Total ash Not more than 16 % (105 °C , 5 hours) Not more than 4 % Acid insoluble ash Not more than 0,5 % Acid insoluble matter Not more than 2 % Arsenic Lead Not more than 3 mg/kg Not more than 5 mg/kg L 334/14 EN Official Journal of the European Communities 9. 12. 98 Mercury Cadmium Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Salmonella spp. E. coli Negative in 10 g Negative in 5 g E 414 ACACIA GUM Synonyms Definition Gum arabic Acacia gum is a dried exudation obtained from the stems and branches of natural 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 Molecular weight Approximately 350 000 Einecs Description Identification A. Solubility Purity Loss on drying 232-519-5 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. 1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol 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 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced Tannin Arsenic Lead Mercury Cadmium To 10 ml of a 1 in 50 solution 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 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/15 Heavy metals (as Pb) Not more than 20 mg/kg Hydrolysis products Mannose, xylose and galacturonic acid are absent (determined by chromatography) Salmonella spp. Negative in 10 g E. coli Negative in 5 g E 415 XANTHAN GUM Definition Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral Molecular weight Approximately 1 000 000 Einecs Assay 234-394-2 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 A. Solubility Purity Soluble in water. Insoluble in ethanol Loss on drying Not more than 15 % (105 °C, 21⁄2 hours) Total ash Pyruvic acid Nitrogen Propane-2-ol Arsenic Lead Mercury Cadmium Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours Not less than 1,5 % Not more than 1,5 % Not more than 500 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Not more than 10 000 colonies per gram Yeast and mould Not more than 300 colonies per gram L 334/16 EN Official Journal of the European Communities 9. 12. 98 E. coli Salmonella spp. Negative in 5 g Negative in 10 g Xanthomonas campestris Viable cells absent E 416 KARAYA-GUM Synonyms Definition Einecs Description Identification A. Solubility Katilo Kadaya Gum sterculia Sterculia Karaya, gum karaya Kullo Kuterra Karaya gum is a dried exudation from the stems and branches of natural 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 232-539-4 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 Insoluble in ethanol B. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gums Purity Loss on drying Total ash Not more than 20 % (105 °C, 5 hours) 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 Arsenic Lead Mercury Cadmium Not detectable Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Salmonella spp. E. coli Negative in 10 g Negative in 5 g 9. 12. 98 EN Official Journal of the European Communities L 334/17 E 417 TARA GUM Definition Einecs Description Identification A. Solubility Tara gum is obtained by grinding the endosperm of the seeds of natural 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)-â-D-mannopyranose units with Æ-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) 254-409-6 A white to white-yellow odourless powder Soluble in water Insoluble in ethanol B. Gel formation To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed Purity Loss on drying Not more than 15 % Ash Not more than 1,5 % Acid insoluble matter Not more than 2 % Protein Starch Arsenic Lead Mercury Cadmium Not more than 3,5 % (factor N x 5,7) Not detectable Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 418 GELLAN GUM Definition Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, 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 Molecular weight Approximately 500 000 L 334/18 EN Official Journal of the European Communities 9. 12. 98 Assay Description Identification A. Solubility Purity Loss on drying Nitrogen Propane-2-ol Arsenic Lead Mercury Cadmium Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2 An off-white powder Soluble in water, forming a viscous solution. Insoluble in ethanol Not more than 15 % after drying (105 °C, 2½ hours) Not more than 3 % Not more than 750 mg/kg Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total plate count Yeast and mould E. coli Salmonella spp. E 422 GLYCEROL Synonyms Definition Chemical names Einecs Chemical formula Molecular weight Assay Description Identification Not more than 10 000 colonies per gram Not more than 400 colonies per gram Negative in 5 g Negative in 10 g Glycerin Glycerine 1,2,3-propanetriol Glycerol Trihydroxypropane 200-289-5 C3H8O3 92,10 Content not less than 98 % of glycerol on the anhydrous basis Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable A. Acrolein formation on heating Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved B. Specific gravity (25/25 °C) Not less than 1,257 C. Refractive index [n]D20 Between 1,471 and 1,474 9. 12. 98 EN Official Journal of the European Communities L 334/19 Purity Water Not more than 5 % (Karl Fischer method) Sulphated ash Not more than 0,01 % determined at 800 – 25 °C Butanetriols Acrolein, compounds Not more than 0,2 % glucose and ammonium Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 °C for five minutes. It neither becomes yellow nor emits an odour of ammonia Fatty acids and esters Not more than 0,1 % calculated as butyric acid Chlorinated compounds Not more than 30 mg/kg (as chlorine) Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg E 431 POLYOXYETHYLENE (40) STEARATE Synonyms Definition Assay Description Identification A. Solubility Polyoxyl (40) stearate, polyoxyethylene (40) monostearate 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 Content not less than 97,5 % on the anhydrous basis Cream-coloured flakes or waxy solid at 25 °C with a faint odour Soluble in water, ethanol, methanol and ethyl acetate Insoluble in mineral oil B. Congealing range 39-44 °C C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Purity Water 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 1,4-Dioxane Not less than 27 and not more than 40 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg L 334/20 EN Official Journal of the European Communities 9. 12. 98 Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20) Synonyms Definition Assay Polysorbate 20 Polyoxyethylene (20) sorbitan monolaurate 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 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 A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Purity Water 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 1,4-Dioxane Not less than 96 and not more than 108 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/21 E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80) Synonyms Definition Assay Polysorbate 80 Polyoxyethylene (20) sorbitan monooleate A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis Description A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour Identification A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Purity Water Not more than 3 % (Karl Fischer method) Acid value Not more than 2 Saponification value Not less than 45 and not more than 55 Hydroxyl value 1,4-Dioxane Not less than 65 and not more than 80 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40) Synonyms Definition Assay Description Polysorbate 40 Polyoxyethylene (20) sorbitan monopalmitate A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour L 334/22 EN Official Journal of the European Communities 9. 12. 98 Identification A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Purity Water Not more than 3 % (Karl Fischer method) Acid value Not more than 2 Saponification value Not less than 41 and not more than 52 Hydroxyl value 1,4-Dioxane Not less than 90 and not more than 107 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60) Synonyms Definition Assay Description Identification A. Solubility Polysorbate 60 Polyoxyethylene (20) sorbitan monostearate A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol Purity Water Not more than 3 % (Karl Fischer method) Acid value Not more than 2 Saponification value Not less than 45 and not more than 55 9. 12. 98 EN Official Journal of the European Communities L 334/23 Hydroxyl value 1,4-Dioxane Not less than 81 and not more than 96 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65) Synonyms Definition Assay Description Identification A. Solubility Polysorbate 65 Polyoxyethylene (20) sorbitan tristearate A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis A tan-coloured, waxy solid at 25 °C with a faint characteristic odour Dispersible in water. Soluble in mineral oil, vegetable oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol C. Congealing range 29-33 °C Purity Water Acid value Not more than 3 % (Karl Fischer method) Not more than 2 Saponification value Not less than 88 and not more than 98 Hydroxyl value 1,4-Dioxane Not less than 40 and not more than 60 Not more than 5 mg/kg Free ethylene oxide Not more than 1 mg/kg Ethylene glycols (mono- and di-) Not more than 0,25 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg L 334/24 EN Official Journal of the European Communities 9. 12. 98 E 440 (i) PECTIN Definition Einecs Assay Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol 232-553-0 Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol Description White, light yellow, light grey or light brown powder Identification A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol Purity Loss on drying Not more than 12 % (105 °C, 2 hours) Acid insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid) Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis Nitrogen content Not more than 1,0 % after washing with acid and ethanol Free methanol, ethanol and propane-2-ol Not more than 1 %, singly or in combination, on the anhydrous basis Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 440 (ii) AMIDATED PECTIN Definition Assay Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol Description White, light yellow, light greyish or light brownish powder 9. 12. 98 EN Official Journal of the European Communities L 334/25 Identification A. Solubility Purity Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol Loss on drying Not more than 12 % (105 °C, 2 hours) Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid) Degree of amidation Not more than 25 % of total carboxyl groups Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basis Nitrogen content Not more than 2,5 % after washing with acid and ethanol Free methanol, ethanol and propane-2-ol Not more than 1 % single or in combination, on a volatile matter-free basis Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 442 AMMONIUM PHOSPHATIDES Synonyms Definition Assay Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N) Description Unctuous semi-solid Identification A. Solubility B. Positive tests for glycerol, for fatty acid and for phosphate Purity Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone Petroleum ether insoluble matter Not more than 2,5 % Arsenic Not more than 3 mg/kg L 334/26 EN Official Journal of the European Communities 9. 12. 98 Lead Mercury Cadmium Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 444 SUCROSE ACETATE ISOBUTYRATE Synonyms Definition SAIB Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6 Einecs 204-771-6 Chemical name Sucrose diacetate hexaisobutyrate Chemical formulae C40H62O19 Molecular weight 832-856 (approximate), C40H62O19 : 846,9 Assay Description Identification Content not less than 98,8 % and not more than 101,9 % of C40H62O19 A pale straw-coloured liquid, clear and free of sediment and having a bland odour A. Solubility Insoluble in water. Soluble in most organic solvents B. Refractive index C. Specific gravity [n]40 D: 1,4492 - 1,4504 [d]25 D: 1,141 - 1,151 Purity Triacetin Acid value Not more than 0,1 % Not more than 0,2 Saponification value Not less than 524 and not more than 540 Arsenic Mercury Cadmium Lead Not more than 3 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Not more than 3 mg/kg Heavy metals (as Pb) Not more than 5 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/27 E 445 GLYCEROL ESTERS OF WOOD ROSIN Synonyms Definition Ester gum A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation Description Hard, yellow to pale amber-coloured solid Identification A. Solubility Insoluble in water, soluble in acetone B. Infrared absorption spectrum Characteristic of the compound Purity Specific gravity of solution 25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, [d]20 boilding point 175,5-176 °C, d20 4: 0,84) Ring and ball softening range Between 82 °C and 90 °C Acid value Hydroxyl value Arsenic Lead Mercury Cadmium Not less than 3 and not more than 9 Not less than 15 and not more than 45 Not more than 3 mg/kg Not more than 2 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Test for absence of tall oil rosin (sulphur test) When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin E 450 (i) DISODIUM DIPHOSPHATE Synonyms Definition Disodium dihydrogen diphosphate Disodium dihydrogen pyrophosphate Sodium acid pyrophosphate Chemical name Disodium dihydrogen diphosphate Einecs 231-835-0 Chemical formula Na2H2P2O7 L 334/28 EN Official Journal of the European Communities 9. 12. 98 Molecular weight 221,94 Assay Content not less than 95 % of disodium diphosphate and not less than 63 % and not more than 64,5 % expressed as P2O5 Description White powder or grains Identification A. Positive tests for sodium and for phosphate B. Solubility Purity Soluble in water pH of a 1 % solution Between 3,7 and 5,0 Loss on drying Not more than 0,5 % (105 °C, 4 hours) Water-insoluble matter Not more than 1 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg (expressed as fluorine) Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 450 (ii) TRISODIUM DIPHOSPHATE Synonyms Definition Einecs 238-735-6 Chemical formula Molecular weight Assay Acid trisodium pyrophosphate Trisodium monohydrogen diphosphate Monohydrate: Anhydrous: Na3HP2O7·H2O Na3HP2O7 Monohydrate: Anhydrous: 261,95 243,93 Content not less than 95 % on the anhydrous basis and not less than 57 % and not more than 59 % expressed as P2O5 Description White powder or grains, occurs anhydrous or as a monohydrate Identification A. Positive tests for sodium and for phosphate B. Soluble in water 9. 12. 98 EN Official Journal of the European Communities L 334/29 Purity pH of a 1 % solution Between 6,7 and 7,3 Loss on ignition 4,5 % on the anhydrous compound 11,5 % on the monohydrous basis Loss on drying Not more than 0,5 % (105 °C, 4 hours) Water-insoluble matter Not more than 0,2 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg expressed as fluorine Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 450 (iii) TETRASODIUM DIPHOSPHATE Synonyms Definition Tetrasodium pyrophosphate Sodium pyrophosphate Chemical name Tetrasodium diphosphate Einecs 231-767-1 Chemical formula Molecular weight Assay Description Identification Anhydrous: Decahydrate: Na4P2O7 Na4P2O7·10 H2O Anhydrous: Decahydrate: 265,94 446,09 Content not less than 95 % of Na4P2O7, in the ignited basis and not less than 52,5 % and not more than 54 % expressed as P2O5 Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air A. Positive tests for sodium and for phosphate B. Solubility Purity Soluble in water. Insoluble in ethanol pH of a 1 % solution Between 9,8 and 10,8 Loss on ignition Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 °C for four hours, followed by ignition at 550 °C for 30 minutes L 334/30 EN Official Journal of the European Communities 9. 12. 98 Water-insoluble matter Not more than 0,2 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg expressed as fluorine Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 450 (v) TETRAPOTASSIUM DIPHOSPHATE Synonyms Definition Potassium pyrophosphate Tetrapotassium pyrophosphate Chemical name Tetrapotassium diphosphate Einecs Chemical formula Molecular weight Assay 230-785-7 K4P2O7 330,34 (anhydrous) Content not less than 95 % on the ignited basis and not less than 42 % and not more than 43,7 % expressed as P2O5 Description Colourless crystals or white, very hygroscopic powder Identification A. Positive tests for potassium and for phosphate B. Solubility Purity Soluble in water, insoluble in ethanol pH of a 1 % solution Between 10,0 and 10,8 Loss on ignition Not more than 2 % after drying at 105 °C for 4 hours then ignition at 550 °C for 30 minutes Water-insoluble matter Not more than 0,2 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg expressed as fluorine Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/31 E 450 (vi) DICALCIUM DIPHOSPHATE Synonyms Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification Calcium pyrophosphate Dicalcium diphosphate Dicalcium pyrophosphate 232-221-5 Ca2P2O7 254,12 Content not less than 96 % and not less than 55 % and not more than 56 % expressed as P2O5 A fine, white, odourless powder A. Positive tests for calcium and for phosphate B. Solubility Purity Insoluble in water. Soluble in dilute hydrochloric and nitric acids pH of a 10 % suspension in water Between 5,5 and 7,0 Loss on ignition Not more than 1,5 % at 800 – 25 °C for 30 minutes Fluoride Arsenic Lead Mercury Cadmium Not more than 50 mg/kg expressed as fluorine Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE Synonyms Definition Acid calcium pyrophosphate Monocalcium dihydrogen pyrophosphate Chemical name Calcium dihydrogen diphosphate Einecs Chemical formula Molecular weight Assay Description 238-933-2 CaH2P2O7 215,97 Content not less than 90 % on the anhydrous basis and not less than 61 % and not more than 64 % expressed as P2O5 White crystals or powder L 334/32 EN Official Journal of the European Communities 9. 12. 98 Identification A. Positive tests for calcium and for phosphate Purity Acid-insoluble matter Not more than 0,4 % Fluoride Arsenic Lead Mercury Cadmium Not more than 30 mg/kg expressed as fluorine Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 451 (i) PENTASODIUM TRIPHOSPHATE Synonyms Definition Pentasodium tripolyphosphate Sodium tripolyphosphate Chemical name Pentasodium triphosphate Einecs 231-838-7 Chemical formulae Na5O10P3·xH2O (x = 0 or 6) Molecular weight 367,86 Assay Content not less than 85 % Content in P2O5 not less than 56 % and not more than 58 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate) Description White, slightly hygroscopic granules or powder Identification A. Solubility Freely soluble in water. Insoluble in ethanol B. Positive tests for sodium and for phosphate C. pH of a 1 % solution Between 9,1 and 10,2 Purity Loss on drying Anhydrous: Not more than 0,7 % (105 °C, 1 hour) Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, followed by drying at 105 °C, 4 hours) Water insoluble matter Not more than 0,1 % 9. 12. 98 EN Official Journal of the European Communities L 334/33 Higher polyphosphates Not more than 1 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE Synonyms Definition Chemical name Einecs Chemical formulae Molecular weight Assay Pentapotassium tripolyphosphate Potassium triphosphate Potassium tripolyphosphate Pentapotassium triphosphate Pentapotassium tripolyphosphate 237-574-9 K5O10P3 448,42 Content not less than 85 % on the dried basis Content in P2O5 not less than 46,5 % and not more than 48 % Description White, hygroscopic powder or granules Identification A. Solubility B. Positive tests for potassium and for phosphate Very soluble in water C. pH of a 1 % solution Between 9,2 and 10,5 Purity Loss on ignition Not more than 0,4 % (105 °C, 4 hours, followed by ignition at 550 °C, 30 minutes) Water insoluble matter Not more than 2 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg L 334/34 EN Official Journal of the European Communities 9. 12. 98 E 452 (i) SODIUM POLYPHOSPHATE 1. SOLUBLE POLYPHOSPHATE Synonyms Definition Sodium hexametaphosphate Sodium tetrapolyphosphate Graham’s salt Sodium polyphosphates, glassy Sodium polymetaphosphate Sodium metaphosphate Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates chains of metaphosphate units, (NaPO3)x where x $ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham’s salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies between 3,0 and 9,0 composed of linear Chemical name Sodium polyphosphate Einecs 272-808-3 Chemical formulae Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2 Molecular weight (102)n Assay Description Identification A. Solubility Content in P2O5 not less than 60 % and not more than 71 % on the ignited basis Colourless or white, transparent platelets, granules, or powders Very soluble in water B. Positive tests for sodium and for phosphate C. pH of a 1 % solution Between 3,0 and 9,0 Purity Loss on ignition Not more than 1 % Water insoluble matter Not more than 0,1 % Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/35 2. INSOLUBLE POLYPHOSPHATE Synonyms Definition Insoluble sodium metaphosphate Maddrell’s salt Insoluble sodium polyphosphate, IMP Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5 Chemical name Sodium polyphosphate Einecs 272-808-3 Chemical formulae Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2 Molecular weight (102)n Assay Description Identification A. Solubility Not less than 68,7 % and not more than 70 % of P2O5 White crystalline powder Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides B. Positive tests for sodium and for phosphate C. pH of a 1 in 3 suspension in water About 6,5 Purity Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 452 (ii) POTASSIUM POLYPHOSPHATE Synonyms Definition Potassium metaphosphate Potassium polymetaphosphate Kurrol salt Chemical name Potassium polyphosphate L 334/36 EN Official Journal of the European Communities 9. 12. 98 Einecs 232-212-6 Chemical formulae (KPO3)n Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where 9n9 is not less than 2 Molecular weight (134)n Assay Content in P2O5 not less than 53,5 % and not more than 61,5 % on the ignited basis Description Fine white powder or crystals or colourless glassy platelets Identification A. Solubility 1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate B. Positive tests for potassium and for phosphate C. pH of a 1 % solution Not more than 7,8 Purity Loss on ignition Not more than 2 % (105 °C, 4 hours followed by ignition at 550 °C, 30 minutes) Water insoluble matter Not more than 0,2 % Cyclic phosphate Not more than 8 % on P2O5 content Fluoride Arsenic Lead Mercury Cadmium Not more than 10 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 452 (iv) CALCIUM POLYPHOSPHATES Synonyms Definition Calcium metaphosphate Calcium polymetaphosphate Chemical name Calcium polyphosphate Einecs 236-769-6 Chemical formulae (CaP2O6)n A heterogeneous mixture of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2 Molecular weight (198)n Assay Description Content in P2O5 not less than 50 % and not more than 71 % on the ignited basis Odourless, colourless crystals or white powder 9. 12. 98 EN Official Journal of the European Communities L 334/37 Identification A. Solubility Usually sparingly soluble in water. Soluble in acid medium B. Positive tests for calcium and for phosphate C. CaO content 27-29,5 % Purity Loss on ignition Cyclic phosphate Fluoride Arsenic Lead Mercury Cadmium Not more than 2 % (105 °C, 4 hours followed by ignition at 550 °C, 30 minutes) Not more than 8 % on P2O5 content Not more than 30 mg/kg Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 460 (i) MICROCRISTALLINE CELLULOSE Synonyms Definition Chemical name Einecs Chemical formula Cellulose gel Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400 Cellulose 232-674-9 (C6H10O5)n Molecular weight About 36 000 Assay Description Identification A. Solubility B. Colour reaction C. To be identified by IR spectroscopy Not less than 97 % calculated as cellulose on the anhydrous basis A fine white or almost white odourless powder Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes, A red colour is produced L 334/38 EN Official Journal of the European Communities 9. 12. 98 D. Suspension test Purity Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears Loss on drying Not more than 7 % (105 °C, 3 hours) Water-soluble matter Not more than 0,24% Sulphated ash Not more than 0,5 % determined at 800 – 25 °C pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5 Starch Not detectable To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced Particle size Not less than 5 em (not more than 10 % of particles of less than 5 em) Carboxyl groups Not more than 1 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 460 (ii) POWDERED CELLULOSE Definition Chemical name Einecs Chemical formula Molecular weight Assay Description Identification A. Solubility Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials Cellulose Linear polymer of 1:4 linked glucose residues 232-674-9 (C6H10O5)n (162)n (n is predominantly 1 000 and greater) Content not less than 92 % A white, odourless powder Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution 9. 12. 98 EN Official Journal of the European Communities L 334/39 B. Suspension test Purity Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears Loss on drying Not more than 7 % (105 °C, 3 hours) Water-soluble matter Not more than 1,0 % Sulphated ash Not more than 0,3 % determined at 800 – 25 °C pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5 Starch Arsenic Lead Mercury Cadmium Not detectable To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Particle size Not less than 5 em (not more than 10 % of particles of less than 5 em) E 461 METHYL CELLULOSE Synonyms Definition Chemical name Chemical formula Cellulose methyl ether Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups Methyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following: — H — CH3 or — CH2CH3 Molecular weight From about 20 000 to 380 000 Assay Description Identification A. Solubility Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH) Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ehtanol, ether and chloroform. Soluble in glacial acetic acid L 334/40 EN Official Journal of the European Communities 9. 12. 98 Purity Loss on drying Sulphated ash Not more than 10 % (105 °C, 3 hours) Not more than 1,5 % determined at 800 – 25 °C pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 463 HYDROXYPROPYL CELLULOSE Synonyms Definition Chemical name Chemical formula Cellulose hydroxypropyl ether Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups Hydroxypropyl ether of cellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following: — H — CH2CHOHCH3 — CH2CHO(CH2CHOHCH3)CH3 — CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3 Molecular weight From about 30 000 to 1 000 000 Assay Description Identification A. Solubility Content not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether B. Gas chromatography Determine the substituents by gas chromotography Purity Loss on drying Sulphated ash Not more than 10 % (105 °C, 3 hours) Not more than 0,5 % determined at 800 – 25 °C pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0 Propylene chlorohydrins Not more than 0,1 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/41 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 464 HYDROXYPROPYL METHYL CELLULOSE Definition Chemical name Chemical formula Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution 2-Hydroxypropyl ether of methylcellulose The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following: — H — CH3 — CH2CHOHCH3 — CH2CHO (CH2CHOHCH3) CH3 — CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3 Molecular weight From about 13 000 to 200 000 Assay Description Identification A. Solubility Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and than 12 % hydroxypropoxyl groups not (-OCH2CHOHCH3), on the anhydrous basis than 3 % and not more less Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol B. Gas chromatography Determine the substituents by gas chromatography Purity Loss on drying Sulphated ash Not more than 10 % (105 °C, 3 hours) Not more than 1,5 % for products with viscosities of 50 mPa. s or above Not more than 3 % for products with viscosities below 50 mPa. s pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0 Propylene chlorohydrins Not more than 0,1 mg/kg Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg L 334/42 EN Official Journal of the European Communities 9. 12. 98 E 465 ETHYL METHYL CELLULOSE Synonyms Definition Methylethylcellulose Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups Chemical name Ethyl methyl ether of cellulose Chemical formula The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following: — H — CH3 — CH2CH3 Molecular weight From about 30 000 to 40 000 Assay Description Identification A. Solubility Purity Loss on drying Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight) Sulphated ash Not more than 0,6 % pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg E 466 SODIUM CARBOXY METHYL CELLULOSE Synonyms Carboxy methyl cellulose CMC NaCMC Sodium CMC Cellulose gum 9. 12. 98 EN Official Journal of the European Communities L 334/43 Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material Chemical name Sodium salt of the carboxymethyl ether of cellulose Chemical formula The polymers contain substituted anhydroglucose units with the following general formula: C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following: — H — CH2COONa — CH2COOH Molecular weight Higher than approximately 17 000 (degree of polymerisation approximately 100) Assay Description Identification A. Solubility B. Foam test C. Precipitate formation D. Colour reaction Purity Degree of substitution Content on the anhydrous basis not less than 99,5 % Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder Yields a viscous colloidal solution with water. Insoluble in ethanol A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers) To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth) Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test: To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit Loss on drying Not more than 12 % (105 °C to constant weight) pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,5 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 20 mg/kg Total glycolate Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis Sodium Not more than 12,4 % on the anhydrous basis L 334/44 EN Official Journal of the European Communities 9. 12. 98 E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS Definition Assay Description Identification A. Solubility B. Positive tests for cations and for fatty acids Purity Sodium Potassium Calcium Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids Content on the anhydrous basis not less than 95 % White or creamy white light powders, flakes or semi-solids Sodium and potassium salts: soluble in water and ethanol calcium salts: insoluble in water, ethanol and ether Not less than 9 % and not more than 14 % expressed as Na2O Not less than 13 % and not more than 21,5 % expressed as K2O Not less than 8,5 % and not more than 13 % expressed as CaO Unsaponifiable matter Not more than 2 % Free fatty acids Not more than 3 % estimated as oleic acid Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Free alkali Not more than 0,1 % expressed as NaOH Matter insoluble in alcohol Not more than 0,2 % (sodium and potassium salts only) E 470b MAGNESIUM SALTS OF FATTY ACIDS Definition Assay Description Identification A. Solubility B. Positive tests for magnesium and for fatty acids Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids Content on the anhydrous basis not less than 95 % White or creamy-white light powders, flakes or semi-solids Insoluble in water, partially soluble in ethanol and ether 9. 12. 98 EN Official Journal of the European Communities L 334/45 Purity Magnesium Free alkali Not less than 6,5 % and not more than 11 % expressed as MgO Not more than 0,1 % expressed as MgO Unsaponifiable matter Not more than 2 % Free fatty acids Not more than 3 % estimated as oleic acid Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Assay Description Identification Glyceryl monostearate Glyceryl monopalmitate Glyceryl monooleate, etc. Monostearin, monopalmitin, monoolein, etc. GMS (for glyceryl monostearate) Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol Content of mono- and diesters: not less than 70 % The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol B. Positive tests for glycerol and for fatty acids C. Solubility Insoluble in water, soluble in ethanol and toluene Purity Water content Acid value Free glycerol Polyglycerols Arsenic Lead Not more than 2 % (Karl Fischer method) Not more than 6 Not more than 7 % Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content Not more than 3 mg/kg Not more than 5 mg/kg L 334/46 EN Official Journal of the European Communities 9. 12. 98 Mercury Cadmium Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total glycerol Sulphated ash Not less than 16 % and not more than 33 % Not more than 0,5 % determined at 800 – 25 °C Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Acetic acid esters of mono- and diglycerides Acetoglycerides Acetylated mono- and diglycerides Acetic and fatty acid esters of glycerol Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides Description Clear, mobile liquids to solids, from white to pale yellow in colour Identification A. Positive tests for glycerol, for fatty acids and for acetic acid B. Solubility Insoluble in water. Soluble in ethanol Purity Acids other than acetic and fatty acids Not detectable Free glycerol Not more than 2 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total acetic acid Not less than 9 % and not more than 32 % Free fatty acids (and acetic acid) Not more than 3 % estimated as oleic acid Total glycerol Sulphated ash Not less than 14 % and not more than 31 % Not more than 0,5 % determined at 800 – 25 °C Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) 9. 12. 98 EN Official Journal of the European Communities L 334/47 E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Description Identification Lactic acid esters of mono- and diglycerides Lactoglycerides Mono- and diglycerides of fatty acids esterified with lactic acid Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour A. Positive tests for glycerol, for fatty acids and for lactic acid B. Solubility Insoluble in cold water but dispersible in hot water Purity Acids other than lactic and fatty acids Not detectable Free glycerol Not more than 2 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total lactic acid Not less than 13 % and not more than 45 % Free fatty acids (and lactic acid) Not more than 3 % estimated as oleic acid Total glycerol Sulphated ash Not less than 13 % and not more than 30 % Not more than 0,5 % determined at 800 – 25 °C Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Citric acid esters of mono- and diglycerides Citroglycerides Mono- and diglycerides of fatty acids esterified with citric acid Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide Description Yellowish or light brown liquids to waxy solids or semi-solids L 334/48 EN Official Journal of the European Communities 9. 12. 98 Identification A. Positive tests for glycerol, for fatty acids and for citric acid B. Solubility Insoluble in cold water Dispersible in hot water Soluble in oils and fats Insoluble in cold ethanol Purity Acids other than citric and fatty acids Not detectable Free glycerol Total glycerol Total citric acid Sulphated ash Arsenic Lead Mercury Cadmium Not more than 2 % Not less than 8 % and not more than 33 % Not less than 13 % and not more than 50 % Not more than 0,5 % determined at 800 – 25 °C Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Free fatty acids Not more than 3 % estimated as oleic acid Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Description Identification Tartaric acid esters of mono- and diglycerides Mono- and diglycerides of fatty acids esterified with tartaric acid Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides Sticky viscous yellowish liquids to hard yellow waxes A. Positive tests for glycerol, for fatty acids and for tartaric acid Purity Acids other than tartaric and fatty acids Not detectable Free glycerol Total glycerol Arsenic Not more than 2 % Not less than 12 % and not more than 29 % Not more than 3 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/49 Lead Mercury Cadmium Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total tartaric acid Not less than 15 % and not more than 50 % Free fatty acids Sulphated ash Not more than 3 % estimated as oleic acid Not more than 0,5 % determined at 800 – 25 °C Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Description Identification Diacetyltartaric acid esters of mono- and diglycerides Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid Diacetyltartaric and fatty acid esters of glycerol Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid Purity Acids other than acetic, tartaric and fatty acids Not detectable Free glycerol Total glycerol Sulphated ash Arsenic Lead Mercury Cadmium Not more than 2 % Not less than 11 % and not more than 28 % Not more than 0,5 % determined at 800 – 25 °C Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total tartaric acid Not less than 10 % and not more than 40 % Total acetic acid Free fatty acids Not less than 8 % and not more than 32 % Not more than 3 % estimated as oleic acid Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) L 334/50 EN Official Journal of the European Communities 9. 12. 98 E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids Description Sticky liquids to solids, from white to pale-yellow in colour Identification A. Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid Purity Acids other than acetic, tartaric and fatty acids Not detectable Free glycerol Total glycerol Sulphated ash Arsenic Lead Mercury Cadmium Not more than 2 % Not less than 12 % and not more than 27 % Not more than 0,5 % determined at 800 – 25 °C Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Total acetic acid Not less than 10 % and not more than 20 % Total tartaric acid Not less than 20 % and not more than 40 % Free fatty acids Not more than 3 % estimated as oleic acid Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 473 SUCROSE ESTERS OF FATTY ACIDS Synonyms Definition Sucroesters Sugar esters Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation dimethylsulphoxide, dimethylformamide, acetate, ethyl 9. 12. 98 EN Official Journal of the European Communities L 334/51 Assay Description Identification A. Positive tests for sugar for fatty Content not less than 80 % Stiff gels, soft solids or white to slightly greyish-white powders acids B. Solubility Purity Sulphated ash Free sugar Free fatty acids Arsenic Lead Mercury Cadmium Sparingly soluble in water Soluble in ethanol Not more than 2 % determined at 800 – 25 °C Not more than 5 % Not more than 3 % estimated as oleic acid Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Methanol Not more than 10 mg/kg Dimethylsulphoxide Not more than 2 mg/kg Dimethylformamide Not more than 1 mg/kg 2-methyl-1-propanol Not more than 10 mg/kg Ethyl acetate Propane-2-ol Propylene glycol Not more than 350 mg/kg, singly or in combination Methyl ethyl ketone Not more than 10 mg/kg Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 474 SUCROGLYCERIDES Synonyms Definition Assay Description Sugar glycerides Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol Content not less than 40 % and not more than 60 % of sucrose fatty acid esters Soft solid masses, stiff gels or white to off-white powders ü ý þ L 334/52 EN Official Journal of the European Communities 9. 12. 98 Identification A. Positive tests for sugar and for fatty acids B. Solubility Purity Sulphated ash Free sugar Free fatty acids Arsenic Lead Mercury Cadmium Insoluble in cold water Soluble in ethanol Not more than 2 % determined at 800 – 25 °C Not more than 5 % Not more than 3 % estimated as oleic acid Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Methanol Not more than 10 mg/kg Dimethylformamide Not more than 1 mg/kg 2-methyl-1-propanol Cyclohexane Ethyl acetate Propane-2-ol Not more than 10 mg/kg, single or in combination Not more than 350 mg/kg, single or in combination Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS Synonyms Definition Assay Description Identification A. Positive for glycerol, polyglycerols and for fatty acids tests Polyglycerol fatty acid esters Polyglycerin esters of fatty acid esters Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol Content of total fatty acid ester not less than 90 % Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids for B. Solubility The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils ü ý þ ü ý þ 9. 12. 98 EN Official Journal of the European Communities L 334/53 Purity Sulphated ash Not more than 0,5 % determined at 800 – 25 °C Acids other than fatty acids Not detectable Free fatty acids Not more than 6 % estimated as oleic acid Total glycerol and polyglycerol Not less than 18 % and not more than 60 % Free glycerol and polyglycerol Not more than 7 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 476 POLYGLYCEROL POLYRICINOLEATE Synonyms Definition Glycerol esters of condensed castor oil fatty acids Polyglycerol esters of polycondensed fatty acids from castor oil Polyglycerol esters of interesterified ricinoleic acid PGPR Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids Description Clear, highly viscous liquid Identification A. Solubility Insoluble in water and in ethanol. Soluble in ether, hydrocarbons and halogenated hydrocarbons B. Positive tests for glycerol, polyglycerol and for ricinoleic acid C. Refractive index [n]65 Between 1,4630 and 1,4665 Purity Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol Hydroxyl value Not less than 80 and not more than 100 Acid value Arsenic Lead Mercury Cadmium Not more than 6 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg L 334/54 EN Official Journal of the European Communities 9. 12. 98 E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS Synonyms Definition Assay Description Identification Propylene glycol esters of fatty acids Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent. Content of total fatty acid ester not less than 85 % Clear liquids or waxy white flakes, beads or solids having a bland odour A. Positive tests for propylene glycol and for fatty acids Purity Sulphated ash Not more than 0,5 % determined at 800 – 25 °C Acids other than fatty acids Not detectable Free fatty acids Not more than 6 % estimated as oleic acid Total propane-1,2-diol Not less than 11 % and not more than 31 % Free propane-1,2-diol Not more than 5 % Dimer and trimer of propylene glycol Not more than 0,5 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate) E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS Synonyms Definition TOSOM Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans Description Pale yellow to light brown a waxy or solid consistency 9. 12. 98 EN Official Journal of the European Communities L 334/55 Identification A. Solubility Purity Melting range Free fatty acids Free glycerol Total fatty acids Total glycerol Insoluble in water. Soluble in hot oil or fat 55—65 °C Not more than 1,5 % estimated as oleic acid Not more than 2 % 83—90 % 16—22 % Fatty acid methyl esters, not forming adduct with urea Not more than 9 % of total fatty acid methyl esters Fatty acids, ether Peroxide value Epoxides Arsenic Lead Mercury Cadmium insoluble in petroleum Not more than 2 % of total fatty acids Not more than 3 Not more than 0,03 % oxirane oxygen Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 481 SODIUM STEAROYL-2-LACTYLATE Synonyms Definition Chemical names Einecs Chemical formula (major components) Sodium stearoyl lactylate Sodium stearoyl lactate A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used Sodium di-2-stearoyl lactate Sodium di(2-stearoyloxy)propionate 246-929-7 C21H39O4Na C19H35O4Na Description White or slightly yellowish powder or brittle solid with a characteristic odour Identification A. Positive tests for sodium, for fatty acids and for lactic acid B. Solubility Insoluble in water. Soluble in ethanol L 334/56 EN Official Journal of the European Communities 9. 12. 98 Purity Sodium Ester value Acid value Not less than 2,5 % and not more than 5 % Not less than 90 and not more than 190 Not less than 60 and not more than 130 Total lactic acid Not less than 15 % and not more than 40 % Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 482 CALCIUM STEAROYL-2-LACTYLATE Synonyms Definition Chemical name Einecs Chemical formula Description Identification Calcium stearoyl lactate A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used Calcium di-2-stearoyl lactate Calcium di(2-stearoyloxy)propionate 227-335-7 C42H78O8Ca C38H70O8Ca White or slightly yellowish powder or brittle solid with a characteristic odour A. Positive tests for calcium, for fatty acids and for lactid acid B. Solubility Slightly soluble in hot water Purity Calcium Ester value Not less than 1 % and not more than 5,2 % Not less than 125 and not more than 190 Total lactic acid Not less than 15 % and not more than 40 % Acid value Arsenic Lead Mercury Cadmium Not less than 50 and not more than 130 Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg 9. 12. 98 EN Official Journal of the European Communities L 334/57 E 483 STEARYL TARTRATE Synonyms Definition Chemical name Chemical formula Molecular weight Assay Stearyl palmityl tartrate Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials Distearyl tartrate Dipalmityl tartrate C38H74O6 to C40H78O6 627 to 655 Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180 Description Cream-coloured unctuous solid (at 25 °C) Identification A. Positive tests for tartare B. Melting range Purity Hydroxyl value Acid value Between 67 °C and 77 °C. After saponification the saturated long chain fatty alcohols have a melting range of 49 °C to 55 °C Not less than 200 and not more than 220 Not more than 5,6 Total tartaric acid content Not less than 18 % and not more than 35 % Sulphated ash Not more than 0,5 % determined at 800 – 25 °C Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg Unsaponifiable matter Not less than 77 % and not more than 83 % Iodine value Not more than 4 (Wijs) E 491 SORBITAN MONOSTEARATE Definition Einecs Assay Description A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid 215-664-9 Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour L 334/58 EN Official Journal of the European Communities 9. 12. 98 Identification A. Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate B. Congealing range 50—52 °C C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol Purity Water Sulphated ash Acid value Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 10 Saponification value Not less than 147 and not more than 157 Hydroxyl value Not less than 235 and not more than 260 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 492 SORBITAN TRISTEARATE Definition Einecs Assay Description Identification A. Solubility A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid 247-891-4 Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol B. Congealing range 47—50 °C C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol 9. 12. 98 EN Official Journal of the European Communities L 334/59 Purity Water Sulphated ash Acid value Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 15 Saponification value Not less than 176 and not more than 188 Hydroxyl value Not less than 66 and not more than 80 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 493 SORBITAN MONOLAURATE Definition Einecs Assay Description Identification A. Solubility A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid 215-663-3 Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour Dispersible in hot and cold water B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol Purity Water Sulphated ash Acid value Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 7 Saponification value Not less than 155 and not more than 170 Hydroxyl value Not less than 330 and not more than 358 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg L 334/60 EN Official Journal of the European Communities 9. 12. 98 E 494 SORBITAN MONOOLEATE Definition Einecs Assay Description Identification A. Solubility A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate 215-665-4 Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water B. Iodine value The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100 Purity Water Sulphated ash Acid value Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 8 Saponification value Not less than 145 and not more than 160 Hydroxyl value Not less than 193 and not more than 210 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 495 SORBITAN MONOPALMITATE Synonyms Definition Einecs Assay Description Sorbitan palmitate A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid 247-568-8 Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour 9. 12. 98 EN Official Journal of the European Communities L 334/61 Identification A. Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water B. Congealing range 45—47 °C C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol Purity Water Sulphate ash Acid value Not more than 2 % (Karl Fischer method) Not more than 0,5 % Not more than 7,5 Saponification value Not less than 140 and not more than 150 Hydroxyl value Not less than 270 and not more than 305 Arsenic Lead Mercury Cadmium Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 508 POTASSIUM CHLORIDE Synonyms Definition Sylvine Sylvite Chemical name Potassium chloride Einecs Chemical formulae Molecular weight Assay Description Identification A. Solubility B. Positive tests for potassium and for chloride 231-211-8 KCl 74,56 Content not less than 99 % on the dried basis Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless Freely soluble in water. Insoluble in ethanol L 334/62 EN Official Journal of the European Communities 9. 12. 98 Purity Loss on drying Not more than 1 % (105 °C, 2 hours) Sodium Arsenic Lead Mercury Cadmium Negative test Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 579 FERROUS GLUCONATE Definition Chemical name Ferrous di-D-gluconate dihydrate Iron(II) di-gluconate dihydrate Einecs 206-076-3 Chemical formulae C12H22FeO14·2H2O Molecular weight 482,17 Assay Description Identification A. Solubility Content not less than 95 % on the dried basis Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar Soluble with slight heating in water. Practically insoluble in ethanol B. Positive test for ferrous ion C. Formation of phenylhydrazine derivative of gluconic acid positive D. pH of a 10 % solution Between 4 and 5,5 Purity Loss on drying Not more than 10 % (105 °C, 16 hours) Oxalic acid Iron (Fe III) Arsenic Lead Mercury Cadmium Not detectable Not more than 2 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg Reducing substances Not more than 0,5 % expressed as glucose 9. 12. 98 EN Official Journal of the European Communities L 334/63 E 585 FERROUS LACTATE Synonyms Definition Iron(II) lactate Iron(II) 2-hydroxy propanoate Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1) Chemical name Ferrous 2-hydroxy propanoate Einecs 227-608-0 Chemical formulae Molecular weight Assay Description Identification A. Solubility C6H10FeO6·xH2O (x = 2 or 3) 270,02 (dihydrate) 288,03 (trihydrate) Content not less than 96 % on the dried basis Greenish-white crystals or light green powder having a characteristic smell Soluble in water. Practically insoluble in ethanol B. Positive test for ferrous ion and for lactate C. pH of a 2 % solution Between 4 and 6 Purity Loss on drying Iron (Fe III) Arsenic Lead Mercury Cadmium Not more than 18 % (100 °C, under vacuum, approximately 700 mm Hg) Not more than 0,6 % Not more than 3 mg/kg Not more than 5 mg/kg Not more than 1 mg/kg Not more than 1 mg/kg’