{ "url": "https://openlegislation.uk/miscellaneous-food-additives-regulations-northern-ireland-1996/schedule-5", "json_url": "https://openlegislation.uk/miscellaneous-food-additives-regulations-northern-ireland-1996/schedule-5.json", "legislation": "nisr/1996/50", "legislation_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996", "legislation_url": "https://openlegislation.uk/miscellaneous-food-additives-regulations-northern-ireland-1996", "path": "schedule/5", "kind": "schedule", "number": "5", "heading": "Purity Criteria", "text": "Each miscellaneous additive for which specific purity criteria are specified or referred to below shall not contain—\n(a) more than 3 milligrams per kilogram of arsenic;\n(b) more than 10 milligrams per kilogram of lead;\n(c) more than 50 milligrams per kilogram of copper, or 25 milligrams per kilogram of zinc or 50 milligrams per kilogram of any combination of copper and zinc;\nexcept in so far as those specific purity criteria provide otherwise or in the case of E 957 Thaumatin.\nDescription\nFine white microcrystalline or amorphous powder\nContent\nNot less than 97 per centum of CaCO3 on a volatile matter-free basis\nVolatile matter\nNot more than 1 per centum (determined by drying at 105°C to constant weight)\nMatter insoluble in hydrochloric acid\nShall comply with the requirement for aluminium, iron, phosphate and matter insoluble in hydrochloric acid in the monograph for chalk in the British Pharmacopoeia 1973 at page 93\nArsenic\nNot more than 5 mg per kg.\nLead\nNot more than 20 mg per kg.\nOther inorganic impurities\nNot more than 100 mg per kg of any of the following substances, namely antimony, copper, chromium, zinc or barium sulphate, or more than 200 mg per kg of any combination of those substances.\nSynonyms\nEthyl 4-hydroxybenzoate\nEthyl ester of p-hydroxybenzoic acid\nSynonyms\nEthyl 4-hydroxybenzoate, sodium salt\nSodium ethyl para-hydroxybenzoate\nSynonyms\nPropyl 4-hydroxybenzoate\nPropyl para-hydroxybenzoate n-propyl p-hydroxybenzoate\nSynonyms\nPropyl 4-hydroxybenzoate, sodium salt\nSodium propyl para-hydroxybenzoate\nSodium n-propyl p-hydroxybenzoate\nSynonyms\nMethyl 4-hydroxybenzoate\nMethyl para-hydroxybenzoate\nSynonyms\nMethyl 4-hydroxybenzoate, sodium salt\nSodium methyl para-hydroxybenzoate\nSynonym\nAcid sodium sulphite\nThe appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC.\nSynonyms\nPotassium bisulhite\nPotassium acid sulphite\nThe appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EEC.\nSynonym\n2-Hydroxybiphenyl\nSynonyms\nSodium biphenyl-2-yl-oxide\nSodium orthophenylphenate\nSynonyms\n2-(Thiazol-4-yl) benzimidazole\n2-(4-thiazolyl) benzimidazole\nThe appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.\nThe criteria in the monograph for nisin contained in the Nutrition Meetings Report Series No. 45A (1969) of the United Nations' Food and Agriculture Organisation at page 53.\nSynonym\nHexamine\nSynonym\nSodium hydrogen diacetate\nThe specific purity criteria for lactic acid contained in Council Directive 65/66/EEC.\nThe appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.\nThe specific purity criteria for carbon dioxide contained in Council Directive 65/66/EEC. Solid or liquid carbon dioxide shall be of equivalent purity to the gas.\nDL-Malic acid\nThe criteria in the monograph for malic acid contained in the Food Chemicals Codex 1972 at page 484 as amended by the Second Supplement to that Codex at page 27, except that the melting range shall be 130°C to 132°C (corrected) and that the method for determining the melting range shall be that specified or a method of equivalent accuracy.\nL-Malic Acid\nDescription\nWhite or nearly white crystalline powder or granules\nContent Melting range\nNot less than 99 per centum of C4H6O5. 99°C to 101°C.\nSpecific rotation [α] 20°C D\nNot less than –2.4° and not more than –2.2° using a solution containing 8.5g L-malic and in 100 ml water.\nMalic acid\nFumaric acid\nResidue on ignition\nWater insoluble matter\nShall comply with the limits given in the }monograph for malic acid in the Food Chemicals Codex 1972 at page 484.\nThe criteria in the monograph for fumaric acid contained in the Food Chemicals Codex 1972 at page 331.\nSynonym\nSodium dihydrogen citrate\nSynonym\nPotassium dihydrogen citrate\nSynonym\nPotassium sodium tartrate\nSynonym\nOrthophosphoric acid\nSynonym\nMonosodium orthophosphate\nSynonym\nDisodium orthophosphate Disodium hydrogen orthophosphate\nSynonym\nTrisodium orthophosphate\nSynonyms\nMonodipotassium orthophosphate Potassium dihydrogen orthophosphate\nSynonyms\nDipotassium orthophosphate Dipotassium hydrogen orthophosphate\nSynonym\nTripotassium orthophosphate\nDescription\nColourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.\nContent\nNot less than 59.5 per centum of C4H4O5Na2.\nMaleic acid\nNot more than 0.05 per centum calculated on the C4H4O5Na2 content.\nDescription\nWhite odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.\nContent\nNot less than 99 per centum of C4H5O5Na on a volatile matter-free basis.\nVolatile matter\nNot more than 2 per centum (determined by drying at 110°C for 3 hours)\nMaleic acid\nNot more than 0.05 per centum.\nDescription\nColourless or almost colourless aqueous solution. Potassium malate may be derived from either DL-malic acid or L-malic acid.\nContent\nNot less than 59.5 per centum of C4H4O5K2\nMaleic acid\nNot more than 0.05 per centum calculated on the C4H4O5K2 content.\nDescription\nWhite odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid\nContent\nNot less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.\nVolatile matter\nNot more than 2 per centum (determined by drying at 110°C for 3 hours)\nMaleic acid\nNot more than 0.05 per centum.\nFluoride\nNot more than 30 mg per kg on a volatile matter-free basis\nDescription\nWhite odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid\nContent\nNot less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.\nVolatile matter\nNot more than 2 per centum (determined by drying at 110°C for 3 hours)\nMaleic acid\nNot more than 0.05 per centum.\nFluoride\nNot more than 30 mg per kg on a volatile matter-free basis\nDescription\nWhite or yellow powder which consists chiefly of a mixture of polyesters obtained by the controlled dehydration of L-(+)-tartaric acid together with unchanged L-(+)-tartaric acid.\nSpecific absorption 1 per centum E 1 cm\nNot more than 1.5 × 10−2at 430 nm. (determined using a filtered aqueous solution).\nIdentification\nPlace 5 to 10 mg of sample in a test tube. Add 2 ml sulphuric acid (about 94 per centum H2SO4) plus two drops of resorcinol reagent (2 g. resorcinol dissolved in 100 ml water plus 0.5 ml sulphuric acid) and heat to 150°C. An intense violet colour is produced.\nContent\nNot less than the equivalent of 105 per centum of tartaric acid (C4H6O6). The esterified tartaric acid content shall be not less than 27 per centum and not more than 38 per centum of the tartaric acid equivalent when determined by the following method:\nAdd three drops of bromothymol blue indicator (0.04 per centum weight/volume solution of bromothymol blue in 95 per centum volume/volume ethanol) to 50 ml of freshly prepared 2 per centum weight/volume cold aqueous solution of metatartaric acid. Titrate with N aqueous sodium hydroxide solution to a blue-green colour (T1ml.). Add a further 20 ml of N aqueous sodium hydroxide solution and leave for 2 hours at room temperature.\nTitrate with N aqueous sulphuric acid solution (T2ml).\nCalculations:\nTartaric acid equivalent=7.5(T1+20-T2)per centum Esterfied tartaric acid=100(20-T2)T1=20-T2per centum\nSpecific rotation [α] 20°C D\nNot less than + 12.5° and not more than + 13.5° (using a filtered 10 per centum weight/volume aqueous solution).\nMatter insoluble in water (at about 20°C)\nNot more than 2.5 per centum (insoluble matter weighed after drying for 3 hours at 70°C in a vacuum oven).\nPyruvic acid\nNot more than 0.5 per centum.\nThe criteria in the monograph for adipic acid contained in the Food Chemicals Codex 1972 at page 21.\nThe criteria in the monograph for succinic acid contained in the Food Chemicals Codex 1972 at page 800.\nSynonym\nAmmonium citrate\nThe criteria in the monograph for ammonium citrate contained in the British Pharmaceutical Codex 1973 at page 830.\nSynonym\nSodium calciumedate\nThe criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.\nSynonym\nPropylene glycol alginate\nThe specific purity criteria for agar contained in Council Directive 78/663/EEC.\nThe specific purity criteria for carrageenan contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.\nSynonym\nCarob gum\nSynonym\nGum arabic\nThe specific purity criteria for xanthan gum contained in Council Directive 78/663/EEC, as amended by Article 1.2(b) of Council Directive 82/504/EEC.\nSynonym\nSterculia gum\nThe criteria in the monograph for karaya gum contained in the Food Chemicals Codex 1981 at page 157.\nAs set out in the Annex to Council Directive 78/663/EEC.\nSynonym\nPolysorbate 20\nThe criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1981 at page 234.\nSynonym\nPolysorbate 80\nThe criteria in the monograph for polysorbate 80 contained in the Food Chemicals Codex 1981 at page 236 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.\nSynonym\nPolysorbate 40\nThe criteria in the monograph for polyoxyethylene (20) sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 278.\nSynonym\nPolysorbate 60\nThe criteria in the monograph for polysorbate 60 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.\nSynonym\nPolysorbate 65\nThe criteria in the monograph for polysorbate 65 contained in the Food Chemicals Codex 1981 at page 235 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.\nDescription\nAmmonium phosphatides exist as an unctuous semi-solid (at 25°C). They consist essentially of a mixture of the ammonium salts of phosphatidic acids derived from partially hardened rapeseed oil together with unreacted partially hardened rape-seed oil.\nMatter insoluble in petroleum ether (40°C-60°C)\nTotal: Not more than 2.5 per centum. Inorganic matter: not more than 0.2 per centum.\npH of an aqueous extract of melted ammonium phosphatides\nNot less than 6.0 and not more than 8.0\nPhosphorus\nNot less than 3.0 per centum and not more than 3.4 per centum.\nAmmonium nitrogen\nNot less than 1.2 per centum and not more than 1.5 per centum.\nArsenic\nNot more than 5 mg per kg.\nSynonyms\nDicalcium pyrophosphate Calcium pyrophosphate\nThe criteria in the monograph for calcium pyrophosphate contained in the Food Chemicals Codex 1972 at page 153.\nDescription\nCalcium polyphosphates exist as a fine white powder or crystals or colourless glassy platelets. They are reproducible heterogeneous mixtures of calcium salts of condensed polyphosphoric acids of general formula:\nH(n+2)PnO(3n+1) where\nn shall be not less than 2\nContent (expressed as P2O5)\nNot less than 50 per centum and not more 71 per centum of an anhydrous basis.\npH (1 per centum aqueous solution)\nFor water soluble phosphates only: not less than 4.0 and not more than 9.0.\nCyclic phosphate\nNot more than 8 per centum calculated on the P2O5 content.\nFluoride\nNot more than 15 mg per kg calculated on the P2O5 content.\nThe specific purity criteria for microcrystalline cellulose contained in Council Directive 78/663/EEC, as amended by Article 1.2(c) of Council Directive 82/504/EEC.\nSynonym\nAlpha-cellulose\nThe criteria in the monograph for cellulose, powdered, contained in the Food Chemicals Codex 1981 at page 80. Additionally the level of lead present shall not exceed 1 mg per kg.\nSynonym\nMethylethylcellulose\nSynonym\nSodium carboyxmethylcellulose\nThe specific purity criteria for carboxymethylcellulose contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.\nSynonym\nAcetylated mono- and diglycerides\nSynonym\nCitroglycerides\nSynonym\nMono- and diacetyl tartaric acid esters of mono-and diglycerides\nThe specific purity criteria for sucrose esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC and Article 1 of Commission Directive 92/4/EEC.\nThe specific purity criteria for sucroglycerides contained in Council Directive 78/663/EEC, as amended by Article 1.2(e) of Council Directive 82/504/EEC.\nThe specific purity criteria for polyglycerol esters of non-polymerised fatty acids contained in Council Directive 78/663/EEC.\nSynonym of castor oil.\nPolyglycerol esters of polycondensed fatty acids\nDescription\nThe polyglycerol esters of polycondensed fatty acids of castor oil exist as a highly viscous liquid (at 25°C). They are essentially a complex mixture of the partial esters and ethers of polyglycerol with linearly interesterified (polycondensed) fatty acids derived from castor oil. The polycondensed castor oil fatty acids are prepared by condensation in the absence of oxygen and have an average of about 5 fatty acid residues per molecule. The polyglycerol moiety is predominantly di-, tri- and tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.\nRefractive index, m65D°C\nNot less than 1.4630 and not more than 1.4665.\nHydroxyl value\nNot less than 80 and not more than 100.\nIodine value\nNot less than 72 and not more than 103 (Wijs).\nAcid value\nNot more than 6 mg KOH per g.\nSynonym\nPropylene glycol esters of fatty acids.\nThe specific purity criteria for propane-1,2-diol esters of fatty acids contained in Council Directive 78/663/EEC, as amended by Article 1.2(f) of Council Directive 82/504/EEC.\nThe criteria in the monograph for sorbitan monostearate contained in the Food Chemicals Codex 1981 at page 307 except that the final sentence of the description (requirement to conform to the regulations of the federal Food and Drug Administration pertaining to specifications for fats or fatty acids derived from edible sources) shall be deleted.\nThe criteria in the monograph for sorbitan tristearate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 297.\nThe criteria in the monograph for sorbitan monolaurate contained in the British Pharmaceutical Codex 1973 at page 465.\nThe criteria in the monograph for sorbitan monooleate contained in the British Pharmaceutical Codex 1973 at page 466.\nThe criteria in the monograph for sorbitan monopalmitate contained in the Food and Nutrition Paper No. 4 (1978) of the United Nations' Food and Agriculture Organisation at page 293.\nDescription\nColourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.\nContent\nNot less than 98 per centum of Na2CO2 on a volatile matter-free basis.\nVolatile matter\nNot more than:\n2 per centum for the non-hydrated substance;\n15 per centum for the monohydrate;\n65 per centum for the decahydrate; (determined by the method for loss on drying in the monograph for sodium carbonate in the Food Chemicals Codex 1972 at page 731.)\nMatter insoluble in dilute ammonia solution\nNot more than 0.12 per centum on a volatile matter-free basis, determined by the following method:\nBoil 5 g of hydrated sodium carbonate, or 2.5 g of anhydrous sodium carbonate, with 50 ml of water and 10 ml of dilute ammonia solution (about 10 per centum NH3). Filter and wash the residue with water, then ignite to constant weight.\nSulphate\nNot more than 0.4 per centum on a volatile matter-free basis.\nChloride\nNot more than 0.4 per centum on a volatile matter-free basis\nIron\nNot more than 40 mg per kg on a volatile matter-free basis.\nSynonym\nSodium bicarbonate\nThe criteria in the monograph for sodium bicarbonate contained in the Food Chemicals Codex 1972 at page 727.\nThe criteria in the monograph for sodium sesqicarbonate contained in the Food Chemicals Codex 1972 at page 765.\nDescription\nThe anhydrous form is a white granular powder.\nThe hydrated form consists of small white translucent crystals or granules.\nContent\nNot less than 98 per centum K2CO3 on a volatile matter-free basis.\nVolatile matter\nNot more than:\n2 per centum for the non-hydrated substance;\n18 per centum for the hydrated substance; (determined by drying at 180°C for 4 hours)\nSynonym\nPotassium bicarbonate\nThe criteria in the monograph for potassium bicarbonate contained in the Food Chemicals Codex 1972 at page 642.\nThe criteria in the monograph for ammonium carbonate contained in the Food Chemicals Codex 1972 at page 45.\nSynonym\nAmmonium bicarbonate\nThe criteria in the monograph for ammonium bicarbonate contained in the Food Chemicals Codex 1972 at page 44.\nThe criteria in the monograph for concentrated hydrochloric acid contained in the European Pharmacopoeia Vol. II, 1971 at page 145.\nThe criteria in the monograph for potassium chloride contained in the Food Chemicals Codex 1972 at page 646.\nThe criteria in the monograph for sulphuric acid contained in the Food Chemicals Codex 1972 at page 802.\nThe criteria in the monograph for sodium sulphate contained in the Food Chemicals Codex 1972 at page 775.\nThe criteria in the monograph for potassium sulphate contained in the Food Chemicals Codex 1972 at page 670.\nThe criteria in the monograph for calcium sulphate contained in the Food Chemicals Codex 1972 at page 163.\nSynonyms\nPotassium aluminium sulphate Potash alum.\nThe criteria in the monograph for alum contained in the European Pharmacopoeia Vol. 1, 1969 at page 243.\nThe criteria in the monograph for sodium hydroxide contained in the Food Chemicals Codex 1972 at page 743.\nThe criteria in the monograph for potassium hydroxide contained in the Food Chemicals Codex 1972 at page 652.\nDescription\nSoft white powder.\nSolubility\n1 g dissolves in 630 ml of water at 25°C, and in 1300 ml of boiling water. Soluble in glycerol and in a saturated solution of sucrose. Insoluble in ethanol.\nContent\nNot less than 92 per centum of Ca(OH)2.\nMatter insoluble in dilute Hydrochloric acid (about 10 per centum weight/ volume HCL)\nNot more than 0.5 per centum.\nMagnesium and alkali salts\nNot more than 6 per centum, determined by the method in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 131 except that the weight of the residue shall not exceed 15 mg.\nCarbonate\nWhen 2 g of calcium hydroxide is mixed with 50 ml of water and an excess of dilute hydrochloric acid (approximately 2N) is added, no more than a slight effervescence is produced.\nSulphate\nNot more than 0.35 per centum.\nFluoride\nNot more than 50 mg per kg.\nThe criteria in the monograph for ammonium hydroxide contained in the Food Chemicals Codex 1972 at page 48.\nThe criteria in the monograph for magnesium hydroxide contained in the British Pharmaceutical Codex 1973 at page 277.\nThe criteria in the monograph for calcium hydroxide contained in the Food Chemicals Codex 1972 at page 138.\nSynonyms\nSodium hexacyanoferrate (II)\nThe criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.\nSynonym\nPotassium hexacyanoferrate (II)\nDescription\nOdourless lemon yellow crystals.\nSolubility\nSoluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.\nContent\nNot less than 98 per centum of K4Fe(CN)6. 3H2O.\nFree moisture\nNot more than 1 per centum (determined by the method for free moisture in the monograph for sodium ferrocyanide in the Food Chemicals Codex 1972 at page 741).\nChloride\nNot more than 0.1 per centum.\nSulphate\nNot more than 0.1 per centum.\nThe criteria in the monograph for sodium aluminium phosphate, acidic contained in the Food Chemicals Codex 1972 at page 722.\nSynonym\nSilica, chemically prepared.\nDescription\nSilica aerogel is a whie fluffy powdered or granular microcellular silica. Hydrated silica is a precipitated hydrated silicon dioxide occurring as a fine white amorphous powder or as beads or granules.\nContent\nSilica aerogel: not less than 90 per centum of SiO2.\nHydrated silica: not less than 91 per centum of SiO2 on a volatile matter-free basis.\nVolatile matter\nHydrated silica: not more than 7 per centum (determined by drying at 105°C for 2 hours).\nLoss on ignition\nNot more than 13 per centum (determined by ignition at 1000°C to constant weight).\nSoluble ionisable salts (expressed as Na2SO4)\nNot more than 5 per centum.\nDescription\nWhite to off-white free-flowing powder.\nSolubility\nInsoluble in water.\nForms a gel with mineral acids.\nContent:\n(expressed as SiO2)\nNot less than 72 per centum and not more than 78 per centum on a volatile matter-free basis.\n(expressed as CaO)\nNot less than 16 per centum and not more than 21 per centum on a volatile matter-free basis.\n(expressed as Na2O)\nNot less than 2 per centum and not more than 4 per centum on a volatile matter-free basis.\nVolatile matter\nNot more than 6 per centum (determined by drying at 105°C for 2 hours).\nLoss on ignition\nNot less than 7 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).\nThe criteria in the monograph for magnesium silicate contained in the Food Chemicals Codex 1972 at page 479.\nThe criteria in the monograph for magnesium trisilicate contained in the British Pharmacopoeia 1973 at page 276.\nDescription\nTalc is a native hydrous magnesium silicate sometimes containing a small proportion of aluminium silicate\nIt shall comply with the requirements for appearance, characteristics and limits of impurities in the monograph for magnesium silicate contained in the Nutrition Meetings Report Series 46B 1970 of the Food and Agriculture Organisation of the United Nations at page 114. The amount of material soluble in dilute hydrochloric acid shall be not more than 2 per centum and the amount of water soluble substances shall be not more than 0.2 per centum.\nSynonyms\nAluminium sodum silicate.\nSodium aluminosilicate.\nSodium silicoaluminate.\nDescription\nFine white amorphous powder or beads.\nContent:\n(expressed as SiO2)\nNot less than 70 per centum and not more than 80 per centum on a volatile matter-free basis.\n(expressed as Al2O3)\nNot less than 8 per centum and not more than 11 per centum on a volatile matter-free basis.\n(expressed as Na2O)\nNot less than 5 per centum and not more than 10 per centum on a volatile matter-free basis.\nVolatile matter\nNot more than 8 per centum (determined by drying at 105°C for 2 hours)\nLoss on ignition\nNot less than 10 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).\nSynonyms\nAluminium calcium silicate.\nCalcium aluminosilicate.\nCalcium silicoaluminate.\nDescription\nFine white free-flowing powder.\nContent:\n(expressed as SiO2)\nNot less than 44 per centum and not more than 50 per centum on a volatile matter-free basis.\n(expressed as Al2O3)\nNot less than 3 per centum and not more than 5 per centum on a volatile matter-free basis.\n(expressed as CaO)\nNot less than 32 per centum and not more than 38 per centum on a volatile matter-free basis.\n(expressed as Na2O)\nNot less than 0.5 per centum and not more than 4 per centum on a volatile matter-free basis.\nVolatile matter\nNot more than 10 per centum (determined by drying at 105°C for 2 hours).\nLoss on ignition\nNot less than 14 per centum and not more than 18 per centum (determined by ignition at 1000°C to constant weight).\nSynonym\nD-Glucono-l,5-lactone\nThe criteria in the monograph for glucono delta-lactone contained in the Food Chemicals Codex 1972 at page 346.\nThe criteria in the monograph for sodium gluconate contained in the Food Chemicals Codex 1972 at page 742.\nDescription\nWhite free-flowing powder.\nSolubility\nFreely soluble in water. Practically insoluble in ethanol and in ether.\nContent\nNot less than 97 per centum of C6H11O7K on a volatile matter-free basis.\nVolatile matter\nNot more than 3 per centum (determined by drying in a vacuum at 105°C for 4 hours).\nReducing substances (expressed as glucose)\nNot more than 0.5 per centum.\nThe criteria in the monograph for calcium gluconate contained in the Food Chemicals Codex 1972 at page 129.\nSynonyms\nSodium hydrogen L-glutamate.\nSodium glutamate.\nGlutamic acid, sodium salt.\nFormula\nC5H8NNaO4.H2O (molecular weight 187.13).\nThe criteria in the monograph for monosodium L-glutamate contained in the Food Chemicals Codex 1981 at page 203.\nSynonyms\nGuanosine 5' -(disodium phosphate)\nSodium 5'-guanylate.\nDisodium guanosine 5'-monophosphate.\nFormula\nC10H12N5Na2O8P.xH2O (molecular weight (anhydrous) 407.20).\nThe criteria in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105.\nSynonyms\nInosine 5'-(disodium phosphate)\nSodium 5'-inosate.\nDisodium inosine 5'-monophosphate.\nFormula\nC10H11N4Na2O8P.xH2O (molecular weight (anhydrous) 392.19).\nThe criteria in the monograph for disodium inosinate contained in the Food Chemicals Codex 1981 at page 106.\nDescription\nWhite or nearly white crystalline powder consisting of a mixture of guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate) in approximately equal proportions.\nSoluble in water, practically insoluble in ethanol.\nContent\nNot less than 97% and not more than 102% of C10H12N5Na2O8P and C10H11N4Na2O8P, and not less than 47% and not more than 53% of C10H12N5Na2O8P or of C10H11N4Na2O8P, in every case calculated on an anhydrous basis.\nMoisture\nNot less than 22% and not more than 26% (Karl Fischer).\npH (5% aqueous solution)\nNot less than 7.0 and not more than 8.5.\nAmmonium salts\nPlace 100 mg of sample in a test tube.\nAdd 50 mg magnesium oxide plus 1 ml of water.\nHeat on a water bath for 5 minutes; the vapour evolved does not affect the colour of moist litmus paper.\nAmino acids\nPlace 5 ml of a 0.1% (weight/volume) solution in a test tube. Add 1 ml of a 2% (weight/volume) solution of ninhydrin and heat for 3 minutes; no blue colour is produced.\nOther nucleotides\nThe paper chromatogram obtained when sodium 5' -ribonucleotide is analysed using the procedure described for “other nucleotides” in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105 shall show no spots other than those for guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate).\nThe criteria in the monograph for glycine contained in the Food Chemicals Codex 1972 at page 359.\nSynonym\nDimethyl silicone.\nAppearance\nClear colourless odourless liquid free from extraneous matter.\nSolubility\nInsoluble in water.\nSoluble in most aliphatic and aromatic hydrocarbon solvents.\nVolatile matter\nNot more than 2 per centum (determined by drying at 200°C for 4 hours).\nIdentification\nShall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.\nAcidity\nShall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.\nTotal silicon\nNot less than 37.3 and not more than 38.5 per centum.\nRefractive index n 25°C D\nNot less than 1.400 and not more than 1.405.\nViscosity (25°C)\nNot less than 300 and not more than 1050 centistokes.\nRelative density d 20°C 4°C\nNot less than 0.960 and not more than 0.980.\nThe criteria in the monograph for carnauba wax contained in the Food Chemicals Codex 1972 at page 170.\nThe standard for machine-made shellac contained in British Standard 3722:1964.\nThe standard for nitrogen type 2 contained in British Standard 4366:1968.\nThe criteria in the monograph for nitrous oxide contained in the European Pharmacopoeia Vol. II 1971 at page 316.\nThe criteria in the monograph for oxygen contained in the European Pharmacopoeia Vol. II 1971 at page 328.\nThe aqueous extract of the product complying with the monograph for Quillaia or for powdered Quillaia, in each case, contained in the British Pharmacopoeia 1980, at page 382.\nDescription\nPolydextrose is an off-white to light tan coloured, water-soluble powder. It consists of a randomly bonded condensation polymer produced by the reaction of D-glucose with sorbitol and citric acid. Free acid groups may be neutralised with potassium hydroxide.\nContent\nNot less than 90% of polymer on an ash-free and water-free basis.\nFree glucose\nNot more than 4% of an ash-free and water-free basis.\nFree 1,6 anhydro-D-glucose\nNot more than 4% on an ash-free and water-free basis.\nFree sorbital\nNot more than 2% on an ash-free and water-free basis.\nWater\nNot more than 4% (Karl Fischer).\npH (10% aqueous solution)\nNot less than 2.5 and not more than 3.5 (not less than 5.0 and not more than 6.0 for the neutralised product).\nSulphated ash\nNot more than 0.3% (not more than 3.0% for the neutralised product).\nArsenic\nNot more than 1 mg/kg.\nLead\nNot more than 1 mg/kg.", "extent": "N.I.", "status": "prospective", "version": "current", "annotations": [ { "type": "footnote", "label": "f1", "text": "O.J. No. L352, 13.12.86, p. 45" }, { "type": "footnote", "label": "f2", "text": "O.J. No. L326, 24.11.90, p. 58" }, { "type": "footnote", "label": "f3", "text": "O.J. No. L55, 29.2.92, p. 96" } ], "outstanding_effects": [ { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": "nisr/1996/50", "affecting_title": "Miscellaneous Food Additives Regulations (Northern Ireland) 1996" }, { "type": "coming into force", "affecting": 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"affecting_title": "Miscellaneous Food Additives (Amendment) Regulations (Northern Ireland) 2001" } ], "provenance": { "source": "legislation.gov.uk", "source_url": "https://www.legislation.gov.uk/nisr/1996/50/schedule/5", "retrieved_at": "2026-10-29T02:37:42.459637+00:00" }, "licence": "Open Government Licence v3.0", "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/", "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives." }