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Regulations 2(1) and 11(3)
Each miscellaneous additive for which specific purity criteria are specified or referred to below shall not contain—
(a)more than 3 milligrams per kilogram of arsenic;
(b)more than 10 milligrams per kilogram of lead;
(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,
except in so far as those specific purity criteria provide otherwise or in the case of E 957 Thaumatin.
E 170(i) Calcium carbonate
Description ... ... ... ... Fine white microcrystalline or amorphous powder
Content ... ... ... ... Not less than 97 per centum of CaCO3 on a volatile matter-free basis
Volatile matter ... ... ... ... Not more than 1 per centum (determined by drying at 105°C to constant weight)
Matter insoluble inhydrochloric acid ... ... ... ... Shall 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
Arsenic ... ... ... ... Not more than 5 mg per kg.
Lead ... ... ... ... Not more than 20 mg per kg.
Other inorganic impurities ... ... ... ... Not 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.
In the case of:—
E 200 Sorbic acid
E 202 Potassium sorbate
E 203 Calcium sorbate
E 210 Benzoic acid
E 211 Sodium benzoate
E 212 Potassium benzoate
E 213 Calcium benzoate
E 214 Ethyl p-hydroxybenzoate
Synonyms ... ... ... ... Ethyl 4-hydroxybenzoate Ethyl ester of p-hydroxybenzoic acid
E 215 Sodium ethyl p-hydroxybenzoate
Synonyms ... ... ... ... Ethyl 4-hydroxybenzoate, sodium salt Sodium ethyl para-hydroxybenzoate
E 216 Propyl p-hydroxybenzoate
Synonyms ... ... ... ... Propyl 4-hydroxybenzoate Propyl para-hydroxybenzoate n-propyl p-hydroxybenzoate
E 217 Sodium propyl p-hydroxybenzoate
Synonyms ... ... ... ... Propyl 4-hydroxybenzoate, sodium salt Sodium propyl para-hydroxybenzoate Sodium n-propyl p-hydroxybenzoate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC(1) as amended by Council Directive 67/428/EEC(2) and Council Directive 76/463/EEC(3).
In the case of:—
E 218 Methyl p-hydroxybenzoate
Synonyms ... ... ... ... Methyl 4-hydroxybenzoate Methyl para-hydroxybenzoate
E 219 Sodium methyl p-hydroxybenzoate
Synonyms ... ... ... ... Methyl 4-hydroxybenzoate, sodium salt Sodium methyl para-hydroxybenzoate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
In the case of:—
E 220 Sulphur dioxide
E 221 Sodium sulphite (anhydrous or heptahydrate)
E 222 Sodium hydrogen sulphite
Synonym ... ... ... ... Acid sodium sulphite
E 223 Sodium metabisulphite
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.
E 224 Potassium metabisulphite
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC.
In the case of:—
E 226 Calcium sulphite
E 227 Calcium hydrogen sulphite
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
E 228 Potassium hydrogen sulphite
Synonyms ... ... ... ... Potassium bisulphite Potassium acid sulphite
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EEC(4).
In the case of:—
E 230 Biphenyl, diphenyl
E 231 Orthophenyl phenol
Synonym ... ... ... ... 2-Hydroxybiphenyl
E 232 Sodium orthophenyl phenol
Synonyms ... ... ... ... Sodium biphenyl-2-yl oxide Sodium orthophenylphenate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC.
E 233 Thiabendazole
Synonyms ... ... ... ... 2-(Thiazol-4-yl) benzimidazole 2-(4-thiazolyl) benzimidazole
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
E 234 Nisin
The 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.
In the case of:—
E 239 Hexamethylene tetramine
Synonym ... ... ... ... Hexamine
E 249 Potassium nitrite
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
In the case of:—
E 250 Sodium nitrite
E 251 Sodium nitrate
E 252 Potassium nitrate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.
In the case of:—
E 260 Acetic acid
E 261 Potassium acetate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC.
E 262(i) Sodium acetate
Sodium acetate, anhydrous
The criteria in the monograph for sodium acetate, anhydrous contained in the Food Chemicals Codex 1972 at page 718.
Sodium acetate
The criteria in the monograph for sodium acetate contained in the Food Chemicals Codex 1972 at page 717 except that the alkalinity shall be not more than 0.1 per centum (as sodium carbonate, Na2 CO3).
In the case of:—
E 262(ii) Sodium diacetate
Synonym ... ... ... ... Sodium hydrogen diacetate
E 263 Calcium acetate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC.
E 270 Lactic acid
The specific purity criteria for lactic acid contained in Council Directive 65/66/EEC.
In the case of:—
E 280 Propionic acid
E 281 Sodium propionate
E 282 Calcium propionate
the appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 67/428/EEC and Council Directive 76/463/EEC.
E 283 Potassium propionate
The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 76/463/EEC.
E 290 Carbon dioxide
The 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.
E 296 Malic acid
DL-Malic acid
The 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.
L-Malic Acid
Description ... ... ... ... White or nearly white crystalline powder or granules
Content ... ... ... ... Not less than 99 per centum of C4H6O5.
Melting range ... ... ... ... 99°C to 101°C.
Specific rotation [α] 20°CD ... ... ... ... Not less than -2.4° and not more than -2.2° using a solution containing 8.5g L-malic and in 100 ml. water).
Maleic acid ... ... ... ... } ... ... ... ...
Fumaric acid ... ... ... ... } ... ... ... ... Shall comply with the limits given in the
Residue on ignition ... ... ... ... } ... ... ... ... monograph for malic acid in the Food
Water insoluble matter ... ... ... ... } ... ... ... ... Chemicals Codex 1972 at page 484.
E 297 Fumaric acid
The criteria in the monograph for fumaric acid contained in the Food Chemicals Codex 1972 at page 331.
In the case of:—
E 300 Ascorbic acid
E 301 Sodium ascorbate
E 302 Calcium ascorbate
E 304 Fatty acid esters of ascorbic acid
E 304(i) Ascorbyl palmitate
E 306 Tocopherol-rich extract
E 307 Alpha-tocopherol
E 308 Gamma-tocopherol
E 309 Delta-tocopherol
E 310 Propyl gallate
E 311 Octyl gallate
E 312 Dodecyl gallate
E 320 Butylated hydroxyanisole (BHA)
E 321 Butylated hydroxytoluene (BHT)
the appropriate specific purity criteria contained in Council Directive No. 78/664/EEC(5).
E 322 Lecithins
The specific purity criteria for lecithins contained in Council Directive No. 78/664/EEC as amended by Article 1.2 of Council Directive 82/712/EEC(6).
In the case of:—
E 325 Sodium lactate
E 326 Potassium lactate
E 327 Calcium lactate
E 330 Citric acid
E 331(i) Monosodium citrate
Synonym ... ... ... ... Sodium dihydrogen citrate
E 331(ii) Disodium citrate
E 331(iii) Trisodium citrate
E 332(i) Monopotassium citrate
Synonym ... ... ... ... Potassium dihydrogen citrate
E 332(ii) Tripotassium citrate
E 333(i) Monocalcium citrate
E 333(ii) Dicalcium citrate
E 333(iii) Tricalcium citrate
E 334 L-(+)-Tartaric acid
E 335(i) Monosodium L-(+)-tartrate
E 335(ii) Disodium L-(+)-tartrate
E 336(i) Monopotassium L-(+)-tartrate
E 336(ii) Dipotassium L-(+)-tartrate
E 337 Sodium Potassium L-(+)-tartrate
Synonym ... ... ... ... Potassium sodium tartrate
E 338 Phosphoric acid
Synonym ... ... ... ... Orthophosphoric acid
E 339(i) Monosodium phosphate
Synonym ... ... ... ... Monosodium orthophosphate
E 339(ii) Disodium phosphate
Synonyms ... ... ... ... Disodium orthophosphate Disodium hydrogen orthophosphate
E 339(iii) Trisodium phosphate
Synonym ... ... ... ... Trisodium orthophosphate
E 340(i) Monopotassium phosphate
Synonyms ... ... ... ... Monopotassium orthophosphate Potassium dihydrogen orthophosphate
E 340(ii) Dipotassium phosphate
Synonyms ... ... ... ... Dipotassium orthophosphate Dipotassium hydrogen orthophosphate
E 340(iii) Tripotassium phosphate
Synonym ... ... ... ... Tripotassium orthophosphate
E 341(i) Monocalcium phosphate
Synonyms ... ... ... ... Monocalcium orthophosphate Calcium tetrahydrogen diorthophosphate
E 341(ii) Dicalcium phosphate
Synonyms ... ... ... ... Dicalcium orthophosphate Calcium hydrogen orthophosphate
E 341(iii) Tricalcium phosphate
Synonyms ... ... ... ... Tricalcium orthophosphate Tricalcium diorthophosphate
the appropriate specific purity criteria contained in Council Directive no. 78/664/EEC.
E 350(i) Sodium malate
Description ... ... ... ... Colourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.
Content ... ... ... ... Not less than 59.5 per centum of C4H4O5Na2.
Maleic acid ... ... ... ... Not more than 0.05 per centum calculated on the C4H4O5Na2 content.
E 350(ii) Sodium hydrogen malate
Description ... ... ... ... White odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.
Content ... ... ... ... Not less than 99 per centum of C4H5O5Na on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 2 per centum (determined by drying at 110°C for 3 hours).
Maleic acid ... ... ... ... Not more than 0.05 per centum.
E 351 Potassium malate
Description ... ... ... ... Colourless or almost colourless aqueous solution Potassium malate may be derived from either DL-malic acid or L-malic acid.
Content ... ... ... ... Not less than 59.5 per centum of C4H4O5K2.
Maleic acid ... ... ... ... Not more than 0.05per centum calculated on the C4H4O5K2 content.
E 352(i) Calcium malate
Description ... ... ... ... White odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid.
Content ... ... ... ... Not less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 2 per centum (determined by drying at 110°C for 3 hours).
Maleic acid ... ... ... ... Not more than 0.05 per centum.
Fluoride ... ... ... ... Not more than 30 mg per kg on a volatile matter-free basis.
E 352(ii) Calcium hydrogen malate
Description ... ... ... ... White odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid.
Content ... ... ... ... Not less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acid ... ... ... ... Not more than 0.05 per centum.
Fluoride ... ... ... ... Not more than 30 mg per kg on a volatile matter-free basis.
E 353 Metatartaric acid
Description ... ... ... ... White 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.
Specific absorption
... ... ... ... Not more than 1.5 × 10−2 at 430 nm. (determined using a filtered aqueous solution).
Identification ... ... ... ... Place 5 to 10mg 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.
Content ... ... ... ... Not 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: Add 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 metartartaric 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. Titrate with N aqueous sulphuric acid solution (T2ml). Calculations:
Specific rotation [α] 20°CD ... ... ... ... Not less than + 12.5° and not more than + 13.5° (using a filtered 10 per centum weight/volume aqueous solution).
Matter insoluble in water(at about 20°C) ... ... ... ... Not more than 2.5 per centum (insoluble matter weighed after drying for 3 hours at 70°C in a vacuum oven).
Pyruvic acid ... ... ... ... Not more than 0.5 per centum.
E 355 Adipic acid
The criteria in the monograph for adipic acid contained in the Food Chemicals Codex 1972 at page 21.
E 363 Succinic acid
The criteria in the monograph for succinic acid contained in the Food Chemicals Codex 1972 at page 800.
E 380 Triammonium citrate
Synonym ... ... ... ... Ammonium citrate
The criteria in the monograph for ammonium citrate contained in the British Pharmaceutical Codex 1973 at page 830.
E 385 Calcium disodium ethylenediamine N N N'N' tetra-acetate
Synonym ... ... ... ... Sodium calciumedetate.
The criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.
In the case of:—
E 400 Alginic acid
E 401 Sodium alginate
E 402 Potassium alginate
E 403 Ammonium alginate
E 404 Calcium alginate
E 405 Propane-1,2-diol alginate
Synonym ... ... ... ... Propylene glycol alginate
the appropriate specific purity criteria contained in Council Directive 78/663/EEC(7) as amended by Article 1.2(a) of Council Directive 82/504/EEC(8).
E 406 Agar
The specific purity criteria for agar contained in Council Directive 78/663/EEC.
E 407 Carrageenan
The specific purity criteria for carrageenan contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC(9).
In the case of:—
E 410 Locust bean gum
Synonym ... ... ... ... Carob gum
E 412 Guar gum
E 413 Tragacanth
E 414 Acacia
Synonym ... ... ... ... Gum arabic
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 415 Xanthan gum
The 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.
E 416 Karaya gum
Synonym ... ... ... ... Sterculia gum.
The criteria in the monograph for karaya gum contained in the Food Chemicals Codex 1981 at page 157.
In the case of:—
E 420(i) Sorbitol
E 420(ii) Sorbitol syrup
E 421 Mannitol
the appropriate specific purity criteria contained in Commission Directive 95/31/EC(10).
E 422 Glycerol
As set out in the Annex to Council Directive 78/663/EEC.
E 432 Polyoxyethylene (20) sorbitan monolaurate
Synonym ... ... ... ... Polysorbate 20.
The criteria in the monograph for polysorbate 20 contained in the Food Chemicals Codex 1981 at page 234.
E 433 Polyoxyethylene (20) sorbitan monooleate
Synonym ... ... ... ... Polysorbate 80
The 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.
E 434 Polyoxyethylene (20) sorbitan monopalmitate
Synonym ... ... ... ... Polysorbate 40.
The 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.
E 435 Polyoxyethylene (20) sorbitan monostearate
Synonym ... ... ... ... Polysorbate 60.
The 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.
E 436 Polyoxyethylene (20) sorbitan tristearate
Synonym ... ... ... ... Polysorbate 65.
The 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.
In the case of:—
E 440(i) Pectin
E 440(ii) Amidated pectin
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 442 Ammonium phosphatides
Description ... ... ... ... Ammonium 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 rapeseed oil.
Matter insoluble in petroleum ether (40°C-60°C) ... ... ... ... Total: Not more than 2.5 per centum. Inorganic matter: Not more than 0.2 per centum.
pH of an aqueous extract of melted ammonium phosphatides ... ... ... ... Not less than 6.0 and not more than 8.0.
Phosphorus ... ... ... ... Not less than 3.0 per centum and not more than 3.4 per centum.
Ammonium nitrogen ... ... ... ... Not less than 1.2 per centum and not more than 1.5 per centum.
Arsenic ... ... ... ... Not more than 5 mg per kg.
In the case of:—
E 450(i) Disodium diphosphate
E 450(ii) Trisodium diphosphate
E 450(iii) Tetrasodium diphosphate
E 450(v) Tetrapotassium diphosphate
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 450(vi) Dicalcium diphosphate
Synonyms ... ... ... ... Dicalcium pyrophosphate Calcium pyrophosphate
The criteria in the monograph for calcium pyrophosphate contained in the Food Chemicals Codex 1972 at page 153.
In the case of:—
E 451(i) Pentasodium triphosphate
E 451(ii) Pentapotassium triphosphate
E 452(i) Sodium polyphosphate
E 452(ii) Potassium polyphosphate
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 452(iv) Calcium polyphosphates
Description ... ... ... ... Calcium 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:
where
n shall be not less than 2.
Content (expressed as P2O5) ... ... ... ... Not less than 50 per centum and not more than 71 per centum on an anhydrous basis.
pH (1 per centum aqueous solution) ... ... ... ... For water soluble phosphates only: not less than 4.0 and not more than 9.0.
Cyclic phosphate ... ... ... ... Not more than 8 per centum calculated on the P2O5 content.
Fluoride ... ... ... ... Not more than 15 mg per kg calculated on the P2O5 content.
E 460(i) Microcrystalline cellulose
The 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.
E 460(ii) Powdered cellulose
Synonym ... ... ... ... Alpha-cellulose
The 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.
In the case of:—
E 461 Methylcellulose
E 463 Hydroxypropylcellulose
E 464 Hydroxypropylmethylcellulose
E 465 Ethylmethylcellulose
Synonym ... ... ... ... Methylethylcellulose
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 466 Carboxymethylcellulose
Synonym ... ... ... ... Sodium carboxymethylcellulose.
The specific purity criteria for carboxymethylcellulose contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.
In the case of:—
E 470a Sodium, potassium and calcium salts of fatty acids
E 471 Monoand diglycerides of fatty acids
E 472(a) Acetic acid esters of monoand diglycerides of fatty acids
Synonym ... ... ... ... Acetylated monoand diglycerides
E 472(b) Lactic acid esters of monoand diglycerides of fatty acids
Synonyms ... ... ... ... Lactylated monoand diglycerides Lactoglycerides
E 472(c) Citric acid esters of monoand diglycerides of fatty acids
Synonym ... ... ... ... Citroglycerides
E 472(d) Tartaric acid esters of monoand diglycerides of fatty acids
E 472(e) Monoand diacetyl tartaric acid esters of monoand diglycerides of fatty acids
Synonym ... ... ... ... Monoand diacetyl tartaric acid esters of monoand diglycerides.
E 472(f) Mixed acetic and tartaric acid esters of monoand diglycerides of fatty acids
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 473 Sucrose esters of fatty acids
The 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(11).
E 474 Sucroglycerides
The 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.
E 475 Polyglycerol esters of fatty acids
The specific purity criteria for polyglycerol esters of non-polymerised fatty acids contained in Council Directive 78/663/EEC.
E 476 Polyglycerol polyricinoleate
Synonym ... ... ... ... Polyglycerol esters of polycondensed fatty acids of castor oil
Description ... ... ... ... The 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-, triand tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.
Refractive index, n65D°C ... ... ... ... Not less than 1.4630 and not more than 1.4665.
Hydroxyl value ... ... ... ... Not less than 80 and not more than 100.
Iodine value ... ... ... ... Not less than 72 and not more than 103 (Wijs).
Acid value ... ... ... ... Not more than 6 mg KOH per g.
E 477 Propane-1,2-diol esters of fatty acids
Synonym ... ... ... ... Propylene glycol esters of fatty acids.
The 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.
In the case of:—
E 481 Sodium stearoyl-2-lactylate
E 482 Calcium stearoyl-2-lactylate
E 483 Stearyl tartrate
the appropriate specific purity criteria contained in Council Directive 78/663/EEC.
E 491 Sorbitan monostearate
The 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.
E 492 Sorbitan tristearate
The 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.
E 493 Sorbitan monolaurate
The criteria in the monograph for sorbitan monolaurate contained in the British Pharmaceutical Codex 1973 at page 465.
E 494 Sorbitan monooleate
The criteria in the monograph for sorbitan monooleate contained in the British Pharmaceutical Codex 1973 at page 466.
E 495 Sorbitan monopalmitate
The 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.
E 500(i) Sodium carbonate
Description ... ... ... ... Colourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.
Content ... ... ... ... Not less than 98 per centum of Na2CO2 on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than: 2 per centum for the non-hydrated substance; 15 per centum for the monohydrate; 65 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.)
Matter insoluble in dilute ammonia solution ... ... ... ... Not more than 0.12 per centum on a volatile matter-free basis, determined by the following method: Boil 5g of hydrated sodium carbonate, or 2.5g of anhydrous sodium carbonate, with 50ml of water and 10ml of dilute ammonia solution (about 10 per centum NH3). Filter and wash the residue with water, then ignite to constant weight.
Sulphate ... ... ... ... Not more than 0.4 per centum on a volatile matter-free basis.
Chloride ... ... ... ... Not more than 0.4 per centum on a volatile matter-free basis.
Iron ... ... ... ... Not more than 40mg per kg on a volatile matter-free basis.
E 500(ii) Sodium hydrogen carbonate
Synonym ... ... ... ... Sodium bicarbonate.
The criteria in the monograph for sodium bicarbonate contained in the Food Chemicals Codex 1972 at page 727.
E 500(iii) Sodium sesquicarbonate
The criteria in the monograph for sodium sesquicarbonate contained in the Food Chemicals Codex 1972 at page 765.
E 501(i) Potassium carbonate
Description ... ... ... ... The anhydrous form is a white granular powder. The hydrated form consists of small white translucent crystals or granules.
Content ... ... ... ... Not less than 98 per centum K2CO3 on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than: 2 per centum for the non-hydrated substance; 18 per centum for the hydrated substance; (determined by drying at 180°C. for 4 hours)
E 501(ii) Potassium hydrogen carbonate
Synonym ... ... ... ... Potassium bicarbonate.
The criteria in the monograph for potassium bicarbonate contained in the Food Chemicals Codex 1972 at page 642.
E 503(i) Ammonium carbonate
The criteria in the monograph for ammonium carbonate contained in the Food Chemicals Codex 1972 at page 45.
E 503(ii) Ammonium hydrogen carbonate
Synonym ... ... ... ... Ammonium bicarbonate.
The criteria in the monograph for ammonium bicarbonate contained in the Food Chemicals Codex 1972 at page 44.
E 504 Magnesium carbonates
Magnesium carbonate, heavy
The criteria in the monograph for heavy magnesium carbonate contained in the European Pharmacopoeia Vol. I, 1969 at page 322.
Magnesium carbonate, light
The criteria in the monograph for light magnesium carbonate contained in the European Pharmacopoeia Vol. I, 1969 at page 321.
E 507 Hydrochloric acid
The criteria in the monograph for concentrated hydrochloric acid contained in the European Pharmacopoeia Vol. II, 1971 at page 145.
E 508 Potassium chloride
The criteria in the monograph for potassium chloride contained in the Food Chemicals Codex 1972 at page 646.
E 509 Calcium chloride
Calcium chloride, anhydrous
The criteria in the monograph for calcium chloride, anhydrous contained in the Food Chemicals Codex 1972 at page 124.
Calcium chloride
Description ... ... ... ... The dihydrate consists of deliquescent white odourless fragments or granules. The hexahydrate consists of deliquescent colourless and odourless crystals.
Content ... ... ... ... Not less than: 98 per centum of CaCl2. 2H2O for the dihydrate; 97 per centum of CaCl2. 6H2O for the hexahydrate.
Magnesium and alkali salts ... ... ... ... Not more than 2 per centum, determined by the method in the monograph for calcium chloride contained in the Food Chemicals Codex 1972 at page 123 except that the weight of the residue shall not exceed 10 mg.
Fluoride ... ... ... ... Not more than 40 mg per kg on an anhydrous basis.
E 513 Sulphuric acid
The criteria in the monograph for sulphuric acid contained in the Food Chemicals Codex 1972 at page 802.
E 514(i) Sodium sulphate
The criteria in the monograph for sodium sulphate contained in the Food Chemicals Codex 1972 at page 775.
E 515(i) Potassium sulphate
The criteria in the monograph for potassium sulphate contained in the Food Chemicals Codex 1972 at page 670.
E 516 Calcium sulphate
The criteria in the monograph for calcium sulphate contained in the Food Chemicals Codex 1972 at page 163.
E 522 Aluminium potassium sulphate
Synonyms ... ... ... ... Potassium aluminium sulphate. Potash alum.
The criteria in the monograph for alum contained in the European Pharmacopoeia Vol. 1, 1969 at page 243.
E 524 Sodium hydroxide
The criteria in the monograph for sodium hydroxide contained in the Food Chemicals Codex 1972 at page 743.
E 525 Potassium hydroxide
The criteria in the monograph for potassium hydroxide contained in the Food Chemicals Codex 1972 at page 652.
E 526 Calcium hydroxide
Description ... ... ... ... Soft white powder
Solubility ... ... ... ... 1 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.
Content ... ... ... ... Not less than 92 per centum of Ca(OH)2.
Matter insoluble in dilute hydrochloric acid (about 10 per centum weight/ volume HCl) ... ... ... ... Not more than 0.5 per centum
Magnesium and alkali salts ... ... ... ... Not 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.
Carbonate ... ... ... ... When 2 g of calcium hydroxide is mixed with 50ml of water and an excess of dilute hydrochloric acid (approximately 2N) is added, no more than a slight effervescence is produced.
Sulphate ... ... ... ... Not more than 0.35 per centum.
Fluoride ... ... ... ... Not more than 50 mg per kg.
E 527 Ammonium hydroxide
The criteria in the monograph for ammonium hydroxide contained in the Food Chemicals Codex 1972 at page 48.
E 528 Magnesium hydroxide
The criteria in the monograph for magnesium hydroxide contained in the British Pharmaceutical Codex 1973 at page 277.
E 529 Calcium oxide
The criteria in the monograph for calcium oxide contained in the Food Chemicals Codex 1972 at page 138.
E 530 Magnesium oxide
Magnesium oxide, heavy
Description ... ... ... ... White fine odourless powder.
Solubility ... ... ... ... Practically insoluble in water. Soluble in dilute acids with, at most, slight effervescence.
Apparent volume ... ... ... ... 20g of heavy magnesium oxide occupies a volume of about 50 ml.
Content ... ... ... ... Not less than 98 per centum of MgO calculated with reference to the ignited substance and determined by the assay method contained in the monograph for light magnesium oxide in the European Pharmacopoeia Vol. I, 1969 at page 319.
Loss on ignition ... ... ... ... Not more than 5 per centum (determined by ignition at 900°C to 950°C to constant weight).
Matter soluble in water ... ... ... ... Not more than 2 per centum, determined by the method for soluble substances contained in the monograph for light magnesium oxide in the European Pharmacopoeia Vol. I, 1969 at page 319.
Matter insoluble in acetic acid ... ... ... ... Not more than 0.1 per centum when determined by the following method: Dissolve 5g heavy magnesium oxide in a mixture of 70 ml acetic acid (see Note 1) and 30 ml water. Heat to boiling for 2 minutes, cool and dilute to 100 ml with dilute acetic acid (see Note 2). Filter through a sintered glass filter. Any residue, after washing with water, drying and ignition at 600°C, shall weigh not more than 5 mg.
Sulphate ... ... ... ... Not more than 0.75 per centum.
Chloride ... ... ... ... Not more than 0.07per centum.
Calcium ... ... ... ... Not more than 2 per centum.
Iron ... ... ... ... Not more than 0.1 per centum.
Arsenic ... ... ... ... Not more than 4 mg per kg.
Heavy metals ... ... ... ... Not more than 40 mg per kg.
Note 1: Acetic acid: contains not less than 29 per centum weight/volume and not more than 31 per centum weight/volume of C2H4O2. Dilute 30 g glacial acetic acid (98 per centum weight/volume C2H4O2) to 100 ml with water.
Note 2: Dilute acetic acid: contains not less than 11.5 per centum weight/volume and not more than 12.5 per centum weight/volume of C2H4O2. Dilute 12 g or 11.7 ml glacial acetic acid (98 per centum weight/volume C2H4O2) to 100 ml with water and, if necessary, adjust the concentration of the solution.
Magnesium oxide, light
The criteria in the monograph for light magnesium oxide contained in the European Pharmacopoeia Vol I, 1969 at page 319.
E 535 Sodium ferrocyanide
Synonym ... ... ... ... Sodium hexacyanoferrate (II)
The criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.
E 536 Potassium ferrocyanide
Synonym ... ... ... ... Potassium hexacyanoferrate (II)
Description ... ... ... ... Odourless lemon yellow crystals.
Solubility ... ... ... ... Soluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.
Content ... ... ... ... Not less than 98 per centum of K4Fe(CN)6. 3H2O.
Free moisture ... ... ... ... Not 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).
Chloride ... ... ... ... Not more than 0.1 per centum.
Sulphate ... ... ... ... Not more than 0.1 per centum.
E 541 Sodium aluminium phosphate, acidic
The criteria in the monograph for sodium aluminium phosphate, acidic contained in the Food Chemicals Codex 1972 at page 722.
E 551 Silicon dioxide
Synonym ... ... ... ... Silica, chemically prepared.
Description ... ... ... ... Silica aerogel is a white 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.
Content ... ... ... ... Silica aerogel: not less than 90 per centum of SiO2. Hydrated silica: not less than 91 per centum of SiO2 on a volatile matter free basis.
Volatile matter ... ... ... ... Hydrated silica: Not more than 7 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition ... ... ... ... Not more than 13 per centum (determined by ignition at 1000°C to constant weight).
Soluble ionisable salts (expressed as Na2SO4) ... ... ... ... Not more than 5 per centum.
E 552 Calcium silicate
Description ... ... ... ... White to off-white free-flowing powder.
Solubility ... ... ... ... Insoluble in water. Forms a gel with mineral acids.
Content (expressed as SiO2) ... ... ... ... Not less than 72 per centum and not more than 78 per centum on a volatile matter-free basis.
(expressed as CaO) ... ... ... ... Not less than 16 per centum and not more than 21 per centum on a volatile matter-free basis.
(expressed as Na2O) ... ... ... ... Not less than 2 per centum and not more than 4 per centum on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 6 per centum (determined by drying at 105°C for 2 hours)
Loss on ignition ... ... ... ... Not less than 7 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).
E 553a(i) ... ... ... ... Magnesium silicate
The criteria in the monograph for magnesium silicate contained in the Food Chemicals Codex 1972 at page 479.
E 553a(ii) Magnesium trisilicate
The criteria in the monograph for magnesium trisilicate contained in the British Pharmacopoeia 1973 at page 276.
E 553b Talc
Description ... ... ... ... Talc is a native hydrous magnesium silicate sometimes containing a small proportion of aluminium silicate.
It 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.
E 554 Sodium aluminium silicate
Synonyms ... ... ... ... Aluminium sodium silicate. Sodium aluminosilicate. Sodium silicoaluminate.
Description ... ... ... ... Fine white amorphous powder or beads.
Content (expressed as SiO2) ... ... ... ... Not less than 70 per centum and not more than 80 per centum on a volatile matter-free basis.
(expressed as Al2O3) ... ... ... ... Not less than 8 per centum and not more than 11 per centum on a volatile matter-free basis.
(expressed as Na2O) ... ... ... ... Not less than 5 per centum and not more than 10 per centum on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 8 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition ... ... ... ... Not less than 10 per centum and not more than 14 per centum (determined by ignition at 1000°C to constant weight).
E 556 Calcium aluminium silicate
Synonyms ... ... ... ... Aluminium calcium silicate. Calcium aluminosilicate. Calcium silicoaluminate.
Description ... ... ... ... Fine white free-flowing powder.
Content (expressed as SiO2) ... ... ... ... Not less than 44 per centum and not more than 50 per centum on a volatile matter-free basis.
(expressed as Al2O3) ... ... ... ... Not less than 3 per centum and not more than 5 per centum on a volatile matter-free basis.
(expressed as CaO) ... ... ... ... Not less than 32 per centum and not more than 38 per centum on a volatile matter-free basis.
(expressed as Na2O) ... ... ... ... Not less than 0.5 per centum and not more than 4 per centum on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 10 per centum (determined by drying at 105°C for 2 hours).
Loss on ignition ... ... ... ... Not less than 14 per centum and not more than 18 per centum (determined by ignition at 1000°C to constant weight).
E 559 Aluminium silicate (Kaolin)
Kaolin, heavy
The criteria in the monograph for heavy kaolin contained in the British Pharmacopoeia 1968 at page 538 as amended by the 1969 Addendum at page 54.
Kaolin, light
The criteria in the monograph for light kaolin contained in the British Pharmacopoeia 1968 at page 539 as amended by the 1969 Addendum at page 54.
E 575 Glucono-delta-lactone
Synonym ... ... ... ... D-Glucono-1,5-lactone
The criteria in the monograph for glucono delta-lactone contained in the Food Chemicals Codex 1972 at page 346.
E 576 Sodium gluconate
The criteria in the monograph for sodium gluconate contained in the Food Chemicals Codex 1972 at page 742.
E 577 Potassium gluconate
Description ... ... ... ... White free-flowing powder.
Solubility ... ... ... ... Freely soluble in water. Practically insoluble in ethanol and in ether.
Content ... ... ... ... Not less than 97 per centum of C6H11O7K on a volatile matter-free basis.
Volatile matter ... ... ... ... Not more than 3 per centum (determined by drying in a vacuum at 105°C for 4 hours)
Reducing substances (expressed as glucose) ... ... ... ... Not more than 0.5 per centum.
E 578 Calcium gluconate
The criteria in the monograph for calcium gluconate contained in the Food Chemicals Codex 1972 at page 129.
E 621 Monosodium glutamate
Synonyms ... ... ... ... Sodium hydrogen L-glutamate. Sodium glutamate. Glutamic acid, sodium salt.
Formula ... ... ... ... C5H8NNaO4.H2O (molecular weight 187.13).
The criteria in the monograph for monosodium L-glutamate contained in the Food Chemicals Codex 1981 at page 203.
E 627 Disodium guanylate
Synonyms ... ... ... ... Guanosine 5' -(disodium phosphate) Sodium 5'-guanylate. Disodium guanosine 5' -monophosphate.
Formula ... ... ... ... C10H12N5Na2O8P.xH2O (molecular weight (anhydrous) 407.20).
The criteria in the monograph for disodium guanylate contained in the Food Chemicals Codex 1981 at page 105.
E 631 Disodium inosinate
Synonyms ... ... ... ... Inosine 5' -(disodium phosphate) Sodium 5' -inosate Disodium inosine 5' -monophosphate
Formula ... ... ... ... C10H11N4Na2O8P.xH2O (molecular weight (anhydrous 392.19).
The criteria in the monograph for disodium inosinate contained in the Food Chemicals Codex 1981 at page 106.
E 635 Disodium 5' -ribonucleotides
Description ... ... ... ... White or nearly white crystalline powder consisting of a mixture of guanosine 5' -(disodium phosphate) and inosine 5' -(disodium phosphate) in approximately equal proportions. Soluble in water, practically insoluble in ethanol.
Content ... ... ... ... Not 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.
Moisture ... ... ... ... Not less than 22% and not more than 26% (Karl Fischer).
pH (5% aqueous solution) ... ... ... ... Not less than 7.0 and not more than 8.5.
Ammonium salts ... ... ... ... Place 100 mg of sample in a test tube. Add 50 mg magnesium oxide plus 1 ml of water. Heat on a water bath for 5 minutes; the vapour evolved does not affect the colour of moist litmus paper.
Amino acids ... ... ... ... Place 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.
Other nucleotides ... ... ... ... The 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).
E 640 Glycine
The criteria in the monograph for glycine contained in the Food Chemicals Codex 1972 at page 359.
E 900 Dimethylpolysiloxane
Synonym ... ... ... ... Dimethyl silicone
Appearance ... ... ... ... Clear colourless odourless liquid free from extraneous matter.
Solubility ... ... ... ... Insoluble in water. Soluble in most aliphatic and aromatic hydrocarbon solvents.
Volatile matter ... ... ... ... Not more than 2 per centum (determined by drying at 200°C for 4 hours).
Identification ... ... ... ... Shall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Acidity ... ... ... ... Shall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Total silicon ... ... ... ... Not less than 37.3 and not more than 38.5 per centum.
Refractive index n25°CD ... ... ... ... Not less than 1.400 and not more than 1.405.
Viscosity (25°C) ... ... ... ... Not less than 300 and not more than 1050 centistokes.
Relative density d 20°C4°C ... ... ... ... Not less than 0.960 and not more than 0.980.
E 901 Beeswax, white and yellow
Beeswax, white
The criteria in the monograph for beeswax, white contained in the Food Chemicals Codex 1972 at page 75, except that the ester value shall be not less than 70 and not more than 80.
Beeswax, yellow
The criteria in the monograph for beeswax, yellow contained in the Food Chemicals Codex 1972 at page 77, except that the ester value shall be not less than 70 and not more than 80.
E 903 Carnauba wax
The criteria in the monograph for carnauba wax contained in the Food Chemicals Codex 1972 at page 170.
E 904 Shellac
The standard for machine-made shellac contained in British Standard 3722:1964.
E 941 Nitrogen
The standard for nitrogen type 2 contained in British Standard 4366: 1968.
E 942 Nitrous oxide
The criteria in the monograph for nitrous oxide contained in the European Pharmacopoeia Vol. II, 1971 at page 316.
E 948 Oxygen
The criteria in the monograph for oxygen contained in the European Pharmacopoeia Vol. II, 1971 at page 328.
In the case of:—
E 950 Acesulfame potassium
E 951 Aspartame
E 953 Isomalt
E 957 Thaumatin
E 959 Neohesperidine DC
E 965(i) Maltitol
E 965(ii) Maltitol syrup
E 966 Lactitol
E 967 Xylitol
the appropriate specific purity criteria contained in Commission Directive 95/31/EEC.
E 999 Extract of Quillaia
The 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.
E 1200 Polydextrose
Description ... ... ... ... Polydextrose 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.
Content ... ... ... ... Not less than 90% of polymer on an ash-free and water-free basis.
Free glucose ... ... ... ... Not more than 4% of an ash-free and water-free basis.
Free 1,6-anhydro-D-glucose ... ... ... ... Not more than 4% on an ash-free and water-free basis.
Free sorbital ... ... ... ... Not more than 2% on an ash-free and water-free basis.
Water ... ... ... ... Not more than 4% (Karl Fischer).
pH (10% aqueous solution) ... ... ... ... Not 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).
Sulphated ash ... ... ... ... Not more than 0.3% (not more than 3.0% for the neutralised product).
Arsenic ... ... ... ... Not more than 1mg/kg.
Lead ... ... ... ... Not more than 1 mg/kg.
Propane-1,2-diol (propylene glycol)
As set out in the Annex to Council Directive 78/663/EEC.
OJ No. L22, 9.2.65, p.373/65 (OJ/SE 1965-66 p.25).
OJ No. L148, 11.7.67, p.148/10 (OJ/SE 1967 p.178).
OJ No. L126, 14.5.76, p.33.
OJ No. L352, 13.12.86, p.45.
OJ No. L223, 14.8.78, p.30.
OJ No. L297, 23.10.82, p.31.
OJ No. L223, 14.8.78, p.7.
OJ No. L230, 5.8.82, p.35.
OJ No. L326, 24.11.90, p.58.
OJ No. L178, 28.7.95, p.1.
OJ No. L55, 29.2.92, p.96.
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