The Miscellaneous Food Additives Regulations 1995

EC No.	Name	Food	Maximum level
E 297	Fumaric acid	(pro memoria)Wine in accordance with Regulation (EEC) No. 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No. 337/79
		Fillings and toppings for fine bakery wares	2.5 g/kg
		Sugar confectionery	1 g/kg
		Gel-like desserts Fruit-flavoured desserts Dry powdered dessert mixes	4 g/kg
		Instant powders for fruit based drinks	1 g/l
		Instant tea powder	1 g/l
		Chewing gum	2 g/kg
	In the following applications, the indicated maximum quantities of phosphoric acid and the phosphates E 338, E 339, E 340, E 341, E 450, E 451 and E 452 may be added individually or in combination (expressed as P₂O₅).
E 338 E 339 E 340 E 341 E 450 E 451	Phosphoric acid Sodium phosphates Monosodium phosphate Disodium phosphate Trisodium phosphate Potassium phosphates Monopotassium phosphate Dipotassium phosphate Tripotassium phosphate Calcium phosphates Monocalcium phosphate Dicalcium phosphate Tricalcium phosphate Diphosphates Disodium diphosphate Trisodium diphosphate Tetrasodium diphosphate Dipotassium diphosphate Tetrapotassium diphosphate Dicalcium diphosphate Calcium dihydrogen diphosphate Triphosphates Pentasodium triphosphate Pentapotassium triphosphate	Non-alcoholic flavoured drinks Sterilised and UHT milk Partly dehydrated milk with less than 28% solids Partly dehydrated milk with more than 28% solids Dried milk and dried skimmed milk Pasteurised, sterilised and UHT creams Whipped cream and vegetable fat analogues Unripened cheese (exceptMozzarella) Processed cheese and processed cheese analogues Meat Products Sport drinks and prepared table waters Dietary supplements Salt and its substitutes Vegetable protein drinks Beverage whiteners Beverage whiteners for vending machines Edible ices	700 mg/l[^f00045] 1 g/l 1 g/kg 1.5 g/kg 2.5 g/kg 5 g/kg 5 g/kg 2 g/kg 20 g/kg 5 g/kg 0.5 g/l quantum satis 10 g/kg 20 g/l 30 g/kg 50 g/kg 1 g/kg
E 452	Polyphosphates Sodium polyphosphate Potassium polyphosphate Sodium calcium polyphosphate Calcium polyphosphates	Desserts Dry powdered dessert mixes Fine bakery wares Flour Flour, self raising Soda bread Liquid egg (white, yolk or whole egg) Sauces Soups and broths Tea and herbal infusions Cider and perry Chewing gum Dried powdered foods Chocolate and malt dairy-based drinks Alcoholic drinks (excluding wine and beer) Breakfast cereals Snacks Surimi Fish and crustacean paste Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products) Special formulae for particular nutritional uses Glazings for meat and vegetable products Sugar confectionery Icing sugar Noodles Batters Fillets of unprocessed fish, frozen and deep-frozen Frozen and deep-frozen crustacean products Processed potato products (including frozen, deep-frozen, chilled and dried processed products)	3 g/kg 7 g/kg 20 g/kg 2.5 g/kg 20 g/kg 20 g/kg 10 g/kg 5 g/kg 3 g/kg 2 g/l 2 g/l quantum satis[^f00046] 10 g/kg[^f00047] 2 g/l 1 g/l 5 g/kg 5 g/kg 1 g/kg 5 g/kg 3 g/kg 5 g/kg 4 g/kg 5 g/kg 10 g/kg 2 g/kg 5 g/kg 5 g/kg 5 g/kg 5 g/kg
E 431	Polyoxyethylene (40) stearate	(pro memoria)Wine in accordance with Regulation (EEC) No. 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No. 337/79
E 353	Metatartaric acid	Wine in accordance with Regulatins (EEC) No. 822/87, (EEC) No. 4252/88, (EEC) No. 2332/92 and (EEC) No. 1873/84 and their implementing regulations
		Made wine	100 mg/l
E 355 E 356 E 357	Adipic acid Sodium adipate Potassium adipate	Fillings and toppings for fine bakery wares Dry powdered dessert mixes Gel-like desserts Fruit-flavoured desserts Powders for home preparation of drinks	2 g/kg 1 g/kg 6 g/kg 1 g/kg 10 g/l expressed as adipic acid
E 363	Succinic acid	Desserts Soups and broths Powders for home preparation of drinks	6 g/kg 5 g/kg 3 g/l
E 385	Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA)	Emulsified sauces Canned and bottled pulses, legumes, mushrooms and artichokes Canned and bottled crustaceans and molluscs Canned and bottled fish Minarine Frozen and deep-frozen crustaceans	75 mg/kg 250 mg/kg 75 mg/kg 75 mg/kg 100 mg/kg 75 mg/kg
E 405	Propane-1,2-diol alginate	Fat emulsions Fine bakery wares Fillings, toppings and coatings for fine bakery wares and desserts Sugar confectionery Water-based edible ices Cereal-and potato-based snacks Sauces Beer Chewing gum Fruit and vegetable preparations Non-alcoholic flavoured drinks Emulsified liqueur Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal Dietary food supplements	3 g/kg 2 g/kg 5 g/kg 1.5 g/kg 3 g/kg 3 g/kg 8 g/kg 100 mg/l 5 g/kg 5 g/kg 300 mg/l 10 g/l 1.2 g/kg 1 g/kg
E 416	Karaya gum	Cerealand potato-based snacks	Nut coatings Fillings, toppings and coatings for fine bakery wares Desserts Emulsified sauces Egg-based liqueurs Dietary food supplements Chewing gum	5 g/kg 10 g/kg 5 g/kg 6 g/kg 10 g/kg 10 g/l quantum satis 5 g/kg
E 420 E 421 E 953 E 965 E 966 E 967	Sorbitol Sorbitol Sorbitol syrup Mannitol Isomalt Maltitol Maltitol Maltitol syrup Lactitol Xylitol	Foods in general (except drinks and those foods referred to in Schedules 6, 7 and 8) Frozen and deep-frozen unprocessed fish, crustaceans, molluscs and cephalopods Liqueurs	quantum satis(for purposes other than sweetening)
E 432 E 433 E 434 E 435 E 436	Polyoxyethylene sorbitan monolaurate (polysorbate 20) Polyoxyethylene sorbitan monooleate (polysorbate 80) Polyoxyethylene sorbitan monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate (polysorbate 60) Polyoxyethylene sorbitan tristearate (polysorbate 65)	Fine bakery wares Fat emulsions for baking purposes Milk and cream analogues Edible ices Desserts Sugar confectionery Emulsified sauces Soups Chewing gum Dietary food supplements Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal	3 g/kg 10 g/kg 5 g/kg 1 g/kg 3 g/kg 1 g/kg 5 g/kg 1 g/kg 5 g/kg quantum satis1 g/kg Individually or in combination
E 442	Ammonium phosphatides	Cocoa and chocolate products as defined in Directive 73/241/EEC[^f00048] Cocoa-based confectionery	10 g/kg 10 g/kg
E 444	Sucrose acetate isobutyrate	Non-alcoholic flavoured cloudy drinks	300 mg/l
E 445	Glycerol esters of wood rosins	Non-alcoholic flavoured cloudy drinks	100 mg/l
E 473 E 474	Sucrose esters of fatty acids Sucroglycerides	Canned liquid coffee Heat-treated meat products Fat emulsions for baking purposes Fine bakery wares Beverage whiteners Edible ices Sugar confectionery Desserts Sauces Soups and broths Fresh fruits, surface treatment Non-alcoholic aniseed-based drinks Non-alcoholic coconut and almond drinks Spirituous beverages (excluding wine and beer) Powders for the preparation of hot beverages Dairy-based drinks Dietary food supplements Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal Chewing gum	1 g/l 5 g/kg (on fat) 10 g/kg 10 g/kg 20 g/kg 5 g/kg 5 g/kg 5 g/kg 10 g/kg 2 g/kg quantum satis5 g/l 5 g/l 5 g/l 10 g/l 5 g/l quantum satis5 g/kg 10 g/kg Individually or in combination
E 475	Polyglycerol esters of fatty acids	Fine bakery wares Emulsified liqueurs Egg products Beverage whiteners Chewing gum Fat emulsions Milk and cream analogues Sugar confectionery Desserts Dietary food supplements Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal Granola-type breakfast cereals	10 g/kg 5 g/l 1 g/kg 0.5 g/kg 5 g/kg 5 g/kg 5 g/kg 2 g/kg 2 g/kg quantum satis5 g/kg 10 g/kg
E 476	Polyglycerol polyricinoleate	Low and very low fat spreads and dressings Cocoa-based confectionery, including chocolate	4 g/kg 5 g/kg
E 477	Propane-1,2-diol esters of fatty acids	Fine bakery wares Fat emulsions for baking purposes Milk and cream analogues Beverage whiteners Edible ices Sugar confectionery Desserts Whipped dessert toppings other than cream Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal	5 g/kg 10 g/kg 5 g/kg 1 g/kg 3 g/kg 5 g/kg 5 g/kg 30 g/kg 1 g/kg
E 479b	Thermally oxidised soya bean oil interacted with monoand diglycerides of fatty acids	Fat emulsions for frying purposes	5 g/kg
E 481 E 482	Sodium stearoyl-2-lactylate Calcium stearoyl-2-lactylate	Fine bakery wares Quick-cook rice Breakfast cereals Emulsified liqueur Spirits with less than 15% alcohol by volume Cereal-based snacks Chewing gum Fat emulsions Desserts Sugar confectionery Beverage whiteners Cerealand potato-based snacks Minced and diced canned meat products Powders for the preparation of hot beverages Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal Bread (except that referred to in Schedule 7) Mostarda di frutta	5 g/kg 4 g/kg 5 g/kg 8 g/l 8 g/l 2 g/kg 2 g/kg 10g/kg 5 g/kg 5 g/kg 3 g/kg 5 g/kg 4 g/kg 2 g/l 2 g/kg 3 g/kg 2 g/kg Individually or in combination
E 483	Stearyl tartrate	Bakery wares (except breads referred to in Schedule 7) Desserts	4 g/kg 5 g/kg
E 491 E 492 E 493 E 494 E 495	Sorbitan monostearate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monopalmitate	Fine bakery wares Toppings and coatings for fine bakery wares Jelly marmalade Fat emulsions Milk and cream analogues Beverage whiteners Liquid tea concentrates and liquid fruit and herbal infusions concentrates Edible ices Desserts Sugar confectionery Cocoa-based confectionery, including chocolate Emulsified sauces Dietary food supplements Yeast for baking Chewing gum Dietetic foods intended for special medical purposes Dietetic formulae for weight control intended to replace total daily food intake or an individual meal(pro memoria)For E 491 only, wine in accordance with Regulation (EEC) No. 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No. 337/79	10 g/kg 5 g/kg 25 mg/kg[^f00049] 10 g/kg 5 g/kg 5 g/kg 0.5 g/l 0.5 g/kg 5 g/kg 5 g/kg 10 g/kg[^f00050] 5 g/kg quantum satis quantum satis 5 g/kg 5 g/kg Individually or in combination
E 512	Stannous chloride	Canned and bottled white asparagus	25 mg/kg as tin
E 520 E 521 E 522 E 523	Aluminium sulphate Aluminium sodium sulphate Aluminium potassium sulphate Aluminium ammonium sulphate
Egg white Candied, crystallised and glacé fruit and vegetables	30 mg/kg 200 mg/kg Individually or in combination, expressed as aluminium
E 541	Sodium aluminium phosphate, acidic	Fine bakery wares (sconesand sponge wares only)	1 g/kg expressed as aluminium
E 535 E 536 E 538	Sodium ferrocyanide Potassium ferrocyanide Calcium ferrocyanide	Salt and its substitutes	20 mg/kg Individually or in combination, expressed as anhydrous potassium ferrocyanide
E 551 E 552 E 553a E 553b E 554 E 555 E 556 E 559	Silicon dioxide Calcium silicate Magnesium silicate Magnesium trisilicate[^f00051] Talc[^f00051] Sodium aluminium silicate Potassium aluminium silicate Calcium aluminium silicate Aluminium silicate (Kaolin)	Dried powdered foods (including sugars) Salt and its substitutes Dietary food supplements Foods in tablet and coated tablet form Sliced hard cheese and sliced processed cheese Chewing gum Rice Sausages (surface treatment only) Moulded jelly sweets (surface treatment only)	10 g/kg 10 g/kg quantum satis quantum satis 10 g/kg Individually or in combination quantum satis[^f00052]
E 579 E 585	Ferrous gluconate Ferrous lactate	Olives darkened by oxidation	150 mg/kg as iron
E 620 E 621 E 622 E 623 E 624 E 625	Glutamic acid Monosodium glutamate Monopotassium glutamate Calcium diglutamate Monoammonium glutamate Magnesium diglutamate	Foods in general (except those referred to in Schedules 6, 7 and 8) Condiments and seasonings	10 g/kg Individually or in combination quantum satis
E 626 E 627 E 628 E 629 E 630 E 631 E 632 E 633 E 634 E 635	Guanylic acid Disodium guanylate Dipotassium guanylate Calcium guanylate Inosinic acid Disodium inosinate Dipotassium inosinate Calcium inosinate Calcium 5'-ribonucleotides Disodium 5'-ribonucleotides	Foods in general (except those referred to in Schedules 6, 7 and 8) Seasonings and condiments	500 mg/kg individually or in combination, expressed as guanylic acid quantum satis
E 900	Dimethyl polysiloxane	Jam, jellies and marmalades as defined in Directive 79/693/EEC and similar fruit spreads, including low calorie products Soups and broths Oils and fats for frying Confectionery (excluding chocolate) Non-alcoholic flavoured drinks Pineapple juice Canned and bottled fruit and vegetables Chewing gum (pro memoria)Wine in accordance with Regulation (EEC) No. 1873/84 authorising the offer or disposal for direct human consumption of certain imported wines which may have undergone oenological processes not provided for in Regulation (EEC) No. 337/79 Sød…saft Batters	10 mg/kg 10 mg/kg 10 mg/kg 10 mg/kg 10 mg/l 10 mg/l 10 mg/kg 100 mg/kg 10 mg/l 10 mg/kg
E 901 E 902 E 903 E 904	Beeswax, white and yellow Candelilla wax Carnauba wax Shellac	As glazing agents only for: Confectionery (including chocolate) Small products of fine bakery wares coated with chocolate Snacks Nuts Coffee beans Dietary food supplements Fresh citrus fruits, melons, apples and pears (surface treatment only)	quantum satis quantum satis quantum satis
E 912 E 914	Montan acid esters Oxidised polyethylene wax	Fresh citrus fruits (surface treatment only)	quantum satis
E 927b	Carbamide	Chewing gum without added sugars	30 g/kg
E 950 E 951 E 957	Acesulfame-K Aspartame Thaumatin	Chewing gum with added sugars	800 mg/kg[^f00053] 2500 mg/kg[^f00053] 10 mg/kg[^f00053] (as flavour enhancer only)
E 959	Neohesperidine DC	Chewing gum with added sugars Margarine Minarine Meat products Fruit jellies Vegetable proteins	150 mg/kg[^f00053] 5 mg/kg (as flavour enhancer only)
E 999	Quillaia extract	Water-based flavoured non-alcoholic drinks	200 mg/l calculated as anhydrous extract
E 1201 E 1202	Polyvinylpyrrolidone Polyvinylpolypyrrolidone	Dietary food supplements in tablet and coated tablet form	quantum satis
E 1505	Triethyl citrate	Dried egg white	quantum satis
	Propane[^f00054] Butane[^f00054] Iso-Butane[^f00054]	Garlic flavoured oil spray for producing garlic bread and pizza Vegetable oil pan spray for professional use only	quantum satis

SCHEDULE 4 — PERMITTED CARRIERS AND CARRIER SOLVENTS

EC No.	Name	Restricted use
	Propan-1,2-diol (propylene glycol)	Colours, emulsifiers, antioxidants and enzymes (maximum 1 g/kg in or on the food)
E 422 E 420 E 421 E 953 E 965 E 966 E 967	Glycerol Sorbitol Mannitol Isomalt Maltitol Lactitol Xylitol
E 400-404	Alginic acid and its sodium, potassium, calcium and ammonium salts
E 405 E 406 E 407 E 410 E 412 E 413 E 414 E 415 E 440	Propan-1,2-diol alginate Agar Carrageenan Locust bean gum Guar gum Tragacanth Acacia gum (gum arabic) Xanthan gum Pectins
E 432 E 433 E 434 E 435 E 436	Polyoxyethylene sorbitan monolaurate (polysorbate 20) Polyoxyethylene sorbitan monooleate (polysorbate 80) Polyoxyethylene sorbitan monopalmitate (polysorbate 40) Polyoxyethylene sorbitan monostearate (polysorbate 60) Polyoxyethylene sorbitan tristearate (polysorbate 65)	Antifoaming agents, colours and fat-soluble antioxidants
E 442	Ammonium phosphatides	Antioxidants
E 460 E 461 E 463 E 464 E 465 E 466	Cellulose (microcrystalline or powdered) Methyl cellulose Hydroxypropyl cellulose Hydroxypropyl methyl cellulose Ethyl methyl cellulose Carboxy methyl cellulose Sodium carboxy methyl cellulose
E 322 E 470b E 471 E 472a E 472c E 472e E 473 E 475	Lecithins Magnesium salts of fatty acids Monoand diglycerides of fatty acids Acetic acid esters of monoand diglycerides of fatty acids Citric acid esters of monoand diglycerides of fatty acids Monoand diacetyl tartaric acid esters of monoand diglycerides of fatty acids Sucrose esters of fatty acids Polyglycerol esters of fatty acids	Colours and fat-soluble antioxidants
E 491 E 492 E 493 E 494 E 495	Sorbitan monostearate Sorbitan tristearate Sorbitan monolaurate Sorbitan monooleate Sorbitan monopalmitate	Colours and anti-foaming agents
E 1404 E 1410 E 1412 E 1413 E 1414 E 1420 E 1422 E 1440 E 1442 E 1450	Oxidised starch Monostarch phosphate Distarch phosphate Phosphated distarch phosphate Acetylated distarch phosphate Acetylated starch Acetylated distarch adipate Hydroxy propyl starch Hydroxy propyl distarch phosphate Starch sodium octenyl succinate
E 170 E 263 E 331 E 332 E 341 E 501 E 504 E 508 E 509 E 511 E 514 E 515 E 516 E 517	Calcium carbonates Calcium acetate Sodium citrates Potassium citrates Calcium phosphates Potassium carbonates Magnesium carbonates Potassium chloride Calcium chloride Magnesium chloride Sodium sulphate Potassium sulphate Calcium sulphate Ammonium sulphate
E 577 E 640 E 1505 E 1518	Potassium gluconate Glycine and its sodium salt Triethyl citrate Glyceryl triacetate (triacetin)
E 551 E 552	Silicon dioxide Calcium silicate	Emulsifiers and colours, max. 5%
E 553b E 558 E 559	Talc Bentonite Aluminium silicate (Kaolin)	Colours, max. 5%
E 901	Beeswax	Colours
E 1200	Polydextrose
E 1201 E 1202	Polyvinylpyrrolidone Polyvinylpolypyrrolidone	Sweeteners

SCHEDULE 5 — PURITY CRITERIA

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[^f00055] as amended by Council Directive 67/428/EEC[^f00056] and Council Directive 76/463/EEC[^f00057].

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[^f00058].

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[^f00059].

• 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[^f00060].

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 $E1per centum1cm$ 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: $Tartaric acid equivalent=7.5(T1+20-T2)per centum.$ $Esterified tartaric acid=10020-T2)T1=20-T2 per centum.$ 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[^f00061] as amended by Article 1.2(a) of Council Directive 82/504/EEC[^f00062].

• 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[^f00063].

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[^f00064].

• 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: $H(n+2)PnO(3n+1)$ 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[^f00065].

• 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.

SCHEDULE 6 — FOODS IN WHICH MISCELLANEOUS ADDITIVES LISTED IN SCHEDULE 1 ARE GENERALLY PROHIBITED

• Unprocessed foods

• Honey as defined in Directive 74/409/EEC[^f00066]

• Non-emulsified oils and fats of animal or vegetable origin

• Butter

• Pasteurised and sterilised (including UHT sterilisation) milk and cream (including skimmed, plain and semi-skimmed)

• Unflavoured, live fermented milk products

• Natural mineral water as defined in Directive 80/777/EEC[^f00067] and spring water

• Coffee (excluding flavoured instant coffee) and coffee extracts

• Unflavoured leaf tea

• Sugars as defined in Directive 73/437/EEC

• Dry pasta

• Natural unflavoured buttermilk (excluding sterilised buttermilk)

SCHEDULE 7 — FOODS IN WHICH A LIMITED NUMBER OF MISCELLANEOUS ADDITIVES LISTED IN SCHEDULE 1 MAY BE USED