The Miscellaneous Food Additives Regulations 1995

Regulations 2(1) and 3(2) to (4) and (7)

SCHEDULE 1 MISCELLANEOUS ADDITIVES GENERALLY PERMITTED FOR USE IN FOODS NOT REFERRED TO IN SCHEDULE 6, 7 OR 8

Notes

(1) The substances listed under numbers E 407 and E 440 may be standardised with sugars, on condition that this is stated in addition to the number and designation.

(2) The substances E 290, E 938, E 939, E 941, E 942 and E 948 may also be used atquantum satisin the foods referred to in Schedules 6, 7 and 8.

(3) The substances E 410, E 412, E 415 and E 417 may not be used to produce dehydrated foods intended to rehydrate on ingestion.

EC No.	Name
E 170	Calcium carbonates (i) Calcium carbonate (ii) Calcium hydrogen carbonate
E 260	Acetic acid
E 261	Potassium acetate
E 262	Sodium acetates (i) Sodium acetate (ii) Sodium hydrogen acetate (sodium diacetate)
E 263	Calcium acetate
E 270	Lactic acid
E 290	Carbon dioxide
E 296	Malic acid
E 300	Ascorbic acid
E 301	Sodium ascorbate
E 302	Calcium ascorbate
E 304	Fatty acid esters of ascorbic acid (i) Ascorbyl palmitate (ii) Ascorbyl stearate
E 306	Tocopherol-rich extract
E 307	Alpha-tocopherol
E 308	Gamma-tocopherol
E 309	Delta-tocopherol
E 322	Lecithins
E 325	Sodium lactate
E 326	Potassium lactate
E 327	Calcium lactate
E 330	Citric acid
E 331	Sodium citrates (i) Monosodium citrate (ii) Disodium citrate (iii) Trisodium citrate
E 332	Potassium citrates (i) Monopotassium citrate (ii) Tripotassium citrate
E 333	Calcium citrates (i) Monocalcium citrate (ii) Dicalcium citrate (iii) Tricalcium citrate
E 334	Tartaric acid (L(+)−)
E 335	Sodium tartrates (i) Monosodium tartrate (ii) Disodium tartrate
E 336	Potassium tartrates (i) Monopotassium tartrate (ii) Dipotassium tartrate
E 337	Sodium potassium tartrate
E 350	Sodium malates (i) Sodium malate (ii) Sodium hydrogen malate
E 351	Potassium malate
E 352	Calcium malates (i) Calcium malate (ii) Calcium hydrogen malate
E 354	Calcium tartrate
E 380	Triammonium citrate
E 400	Alginic acid
E 401	Sodium alginate
E 402	Potassium alginate
E 403	Ammonium alginate
E 404	Calcium alginate
E 406	Agar
E 407	Carrageenan
E 410	Locust bean gum
E 412	Guar gum
E 413	Tragacanth
E 414	Acacia gum (gum arabic)
E 415	Xanthan gum
E 417	Tara gum
E 418	Gellan gum
E 422	Glycerol
E 440	Pectins (i) pectin (ii) amidated pectin
E 460	Cellulose (i) Microcrystalline cellulose (ii) Powdered cellulose
E 461	Methyl cellulose
E 463	Hydroxypropyl cellulose
E 464	Hydroxypropyl methyl cellulose
E 465
Ethyl methyl cellulose
E 466	Carboxy methyl cellulose Sodium carboxy methyl cellulose
E 470a	Sodium, potassium and calcium salts of fatty acids
E 470b	Magnesium salts of fatty acids
E 471	Monoand diglycerides of fatty acids
E 472a	Acetic acid esters of monoand diglycerides of fatty acids
E 472b	Lactic acid esters of monoand diglycerides of fatty acids
E 472c	Citric acid esters of monoand diglycerides of fatty acids
E 472d	Tartaric acid esters of monoand diglycerides of fatty acids
E 472e	Monoand diacetyl tartaric acid esters of monoand diglycerides of fatty acids
E 472f	Mixed acetic and tartaric acid esters of monoand diglycerides of fatty acids
E 500	Sodium carbonates (i) Sodium carbonate (ii) Sodium hydrogen carbonate (iii) Sodium sesquicarbonate
E 501	Potassium carbonates (i) Potassium carbonate (ii) Potassium hydrogen carbonate
E 503	Ammonium carbonates (i) Ammonium carbonate (ii) Ammonium hydrogen carbonate
E 504	Magnesium carbonates (i) Magnesium carbonate (ii) Magnesium hydroxide carbonate (syn.: Magnesium hydrogen carbonate)
E 507	Hydrochloric acid
E 508	Potassium chloride
E 509	Calcium chloride
E 511	Magnesium chloride
E 513	Sulphuric acid
E 514	Sodium sulphates (i) Sodium sulphate (ii) Sodium hydrogen sulphate
E 515	Potassium sulphates (i) Potassium sulphate (ii) Potassium hydrogen sulphate
E 516	Calcium sulphate
E 524	Sodium hydroxide
E 525	Potassium hydroxide
E 526	Calcium hydroxide
E 527	Ammonium hydroxide
E 528	Magnesium hydroxide
E 529	Calcium oxide
E 530	Magnesium oxide
E 570	Fatty acids
E 574	Gluconic acid
E 575	Glucono-delta-lactone
E 576	Sodium gluconate
E 577	Potassium gluconate
E 578	Calcium gluconate
E 640	Glycine and its sodium salt
E 938	Argon
E 939	Helium
E 941	Nitrogen
E 942	Nitrous oxide
E 948	Oxygen
E 1200	Polydextrose
E 1404	Oxidised starch
E 1410	Monostarch phosphate
E 1412	Distarch phosphate
E 1413	Phosphated distarch phosphate
E 1414	Acetylated distarch phosphate
E 1420	Acetylated starch
E 1422	Acetylated distarch adipate
E 1440	Hydroxy propyl starch
E 1442	Hydroxy propyl distarch phosphate
E 1450	Starch sodium octenyl succinate

Regulations 2(1) and 3(5)

SCHEDULE 2 CONDITIONALLY PERMITTED PRESERVATIVES AND ANTIOXIDANTS

PART A Sorbates, benzoates and p-hydroxybenzoates

EC No.	Name	Abbreviation
Notes 1. The levels of all substances mentioned above are expressed as the free acid. 2. The abbreviations used in the table mean the following: Sa + Ba: Sa and Ba used singly or in combination Sa + PHB: Sa and PHB used singly or in combination Sa + Ba + PHB: Sa, Ba and PHB used singly or in combination. 3. The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers' instructions.
(1) Benzoic acid may be present in certain fermented products resulting from the fermentation process following good manufacturing practice.
E 200 E 202 E 203	Sorbic acid Potassium sorbate Calcium sorbate	} Sa
E 210 E 211 E 212 E 213	Benzoic acid Sodium benzoate Potassium benzoate Calcium benzoate	} Ba(1)
E 214 E 215 E 216 E 217 E 218 E 219
Ethyl p-hydroxybenzoate Sodium ethyl p-hydroxybenzoate Propyl p-hydroxybenzoate Sodium propyl p-hydroxybenzoate Methyl p-hydroxybenzoate Sodium methyl p-hydroxybenzoate	} PHB

Food	Maximum level (mg/kg or mg/l as appropriate)
	Sa	Ba	PHB	Sa + Ba	Sa + PHB	Sa + Ba + PHB
Wine-based flavoured drinks including products covered by Regulation (EEC) No. 1601/91(1)	200
Non-alcoholic flavoured drinks (excluding dairy-based drinks)	300	150		250 Sa+ 150 Ba
Liquid tea concentrates and liquid fruit and herbal infusion concentrates				600
Grape juice, unfermented, for sacramental use				2000
Wines as referred to in Regulation (EEC) No. 822/87(2); alcohol-free wine; fruit wine (including alcohol-free);made wine; cider and perry (including alcohol-free)	200
Sød… Saft or Sødet… Saft	500	200
Alcohol-free beer in keg		200
Mead	200
Spirits with less than 15% alcohol by volume	200	200		400
Fillings of ravioli and similar products	1000
Low-sugar jams, jellies, marmalades and similar low calorie or sugar-free products and other fruit-based spreads;Mermeladas		500		1000
Candied, crystallised and glacé fruit and vegetables				1000
Dried fruit	1000
FrugtgrødandRote Grütze	1000	500
Fruit and vegetable preparations including fruit-based sauces, excluding purée, mousse, compote, salads and similar products, canned or bottled	1000
Vegetables in vinegar, brine or oil (excluding olives)				2000
Potato dough and pre-fried potato slices	2000
Gnocchi	1000
Polenta	200
Olives and olive-based preparations	1000
Jelly coatings of meat products (cooked, cured or dried); Paté					1000
Surface treatment of dried meat products						quantum satis
Semi-preserved fish products including fish roe products				2000
Salted, dried fish				200
Shrimps, cooked				2000
Crangon crangonandCrangon vulgaris,cooked				6000
Cheese, pre-packed, sliced	1000
Unripened cheese	1000
Processed cheese	2000
Layered cheese and cheese with added foods	1000
Non-heat-treated dairy-based desserts				300
Curdled milk	1000
Liquid egg (white, yolk or whole egg)				5000
Dehydrated, concentrated, frozen and deep-frozen egg products	1000
Pre-packed sliced bread and rye-bread	2000
Partially baked, pre-packed bakery wares intended for retail sale	2000
Fine bakery wares with a water activity of more than 0.65	2000
Cerealor potato-based snacks and coated nuts					1000 (max. 300 PHB)
Batters	2000
Confectionery (excluding chocolate)						1500 (max. 300 PHB)
Chewing gum				1500
Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)	1000
Fat emulsions (excluding butter) with a fat content of 60% or more	1000
Fat emulsions with a fat content less than 60%	2000
Emulsified sauces with a fat content of 60% or more	1000
Emulsified sauces with a fat content less than 60%	2000
Non-emulsified sauces				1000
Prepared salads				1500
Mustard				1000
Seasonings and condiments				1000
Liquid soups and broths (excluding canned)				500
Aspic	1000	500
Liquid dietary food supplements						2000
Dietetic foods intended for special medical purposes excluding foods for infants and young children as referred to in Directive 89/398/EEC dietetic formulae for weight control intended to replace total daily food intake or an individual meal				1500

PART B Sulphur dioxide and sulphites

EC No.	Name
Notes (1) Maximum levels are expressed as SO2 in mg/kg or mg/l as appropriate and relate to the total quantity, available from all sources. (2) An SO2 content of not more than 10 mg/kg or 10 mg/l is not considered to be present.
E 220	Sulphur dioxide
E 221	Sodium sulphite
E 222	Sodium hydrogen sulphite
E 223	Sodium metabisulphite
E 224	Potassium metabisulphite
E 226	Calcium sulphite
E 227	Calcium hydrogen sulphite
E 228	Potassium hydrogen sulphite

Food	Maximum level (mg/kg or mg/l as appropriate) Expressed as SO2
Burger meatwith a minimum vegetable and/or cereal content of 4%	450
Breakfast sausages	450
Longaniza frescaandButifarra fresca	450
Dried salted fish of the `Gadidae' species	200
Crustaceans and cephalopods – fresh, frozen and deep-frozen crustaceans,	150(3)
penaeidae solenceridae, aristeidaefamily:
up to 80 units	150(3)
between 80 and 120 units	200(3)
over 120 units	300(3)
cooked	50(3)
Dry biscuit	50
Starches (excluding starches for weaning foods, follow-on formulae and infant formulae)	50
Sago	30
Pearl barley	30
Dehydrated granulated potatoes	400
Cereal-and potato-based snacks	50
Peeled potatoes	50
Processed potatoes (including frozen and deep-frozen potatoes)	100
Potato dough	100
White vegetables, dried	400
White vegetables, processed (including frozen and deep-frozen white vegetables)	50
Dried ginger	150
Dried tomatoes	200
Horseradish pulp	800
Onion, garlic and shallot pulp	300
Vegetables and fruits in vinegar, oil or brine (except olives and golden peppers in brine)	100
Golden peppers in brine	500
Processed mushrooms (including frozen mushrooms)	50
Dried mushrooms	100
Dried fruits
apricots, peaches, grapes, prunes and figs	2000
bananas	1000
apples and pears	600
other (including nuts in shell)	500
Dried coconut	50
Candied, crystallised or glacé fruit, vegetables, angelica and citrus peel	100
Jam, jelly and marmalade as defined in Directive 79/693/EEC(4) (except extra jam and extra jelly) and other similar fruit spreads including low-calorie products	50
Jams, jelliesandmarmaladesmade with sulphited fruit	100
Fruit-based pie fillings	100
Citrus-juice-based seasonings	200
Concentrated grape juice for home wine-making	2000
Mostarda di frutta	100
Jellying fruit extract, liquid pectin for sale to the final consumer	800
Bottled whiteheart cherries, rehydrated dried fruit and lychees	100
Bottled, sliced lemon	250
Sugars as defined in Directive 73/437/EEC(5) except glucose syrup, whether or not dehydrated	15
Glucose syrup, whether or not dehydrated	20
Treacle and molasses	70
Other sugars	40
Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)	40
Orange, grapefruit, apple and pineapple juice for bulk dispensing in catering establishments	50
Lime and lemon juice	350
Concentrates based on fruit juice and containing not less than 2.5% barley (barley water)	350
Other concentrates based on fruit juice or comminuted fruit;capilé groselha	250
Non-alcoholic flavoured drinks containing fruit juice	20 (carry-over from concentrates only)
Non-alcoholic flavoured drinks containing at least 235 g/l glucose syrup	50
Grape juice, unfermented, for sacramental use	70
Glucose-syrup-based confectionery	50 (carry-over from the glucose syrup only)
Beer including low-alcohol and alcohol-free beer	20
Beer with a second fermentation in the cask	50
Wines	in accordance with Regulations (EEC) No. 822/87, (EEC) No. 4252/88(6), (EEC) No. 2332/92(7) and (EEC) No. 1873/84(8) and their implementing regulations; (pro memoria) 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(9).
Alcohol-free wine	200
Made wine	260
Cider, perry, fruit wine, sparkling fruit wine (including alcohol-free products)	200
Mead	200
Fermentation vinegar	170
Mustard, excluding Dijon mustard	250
Dijon mustard	500
Gelatin	50
Vegetableand cereal-protein-based meat, fish and crustacean analogues	200

PART C Other preservatives

EC No.	Name	Food	Maximum level
E 230	Biphenyl, diphenyl	Surface treatment of citrus fruits	70 mg/kg
E 231 E 232	Orthophenyl phenol } Sodium orthophenyl phenol }	Surface treatment of citrus fruits	12 mg/kg individually or in combination expressed as orthophenyl phenol
E 233	Thiabendazole	Surface treatment of: citrus fruit bananas	6 mg/kg 3 mg/kg
E 234	Nisin(10)	Semolina and tapioca puddings and similar products Ripened cheese and processed cheese Clotted cream	3 mg/kg 12.5 mg/kg 10 mg/kg
E 235	Natamycin	Surface treatment of: hard, semi-hard and semi-soft cheese dried, cured sausages	} 1 mg/dm2 surface (not present at a depth of 5 mm)
E 239	Hexamethylene tetramine	Provolonecheese	25 mg/kg residual amount, expressed as formaldehyde
E 242	Dimethyl dicarbonate	Non-alcoholic flavoured drinks Alcohol-free wine Liquid-tea concentrate	} 250 mg/l ingoing amount, residues not detectable
E 284 E 285	Boric acid Sodium tetraborate (borax)	Sturgeons' eggs (Caviar)	4 g/kg expressed as boric acid

EC No.	Name	Food	Indicative ingoing amount mg/kg	Residual amount mg/kg
E 249 E 250	Potassium nitrite(11) Sodium nitrite(11)	Non-heat-treated, cured, dried meat products Other cured meat products Canned meat productsFoie gras, foie gras entier, blocs de foie gras Cured bacon	150(12) 150(12)	50(13) 100(13) 175(13)
E 251 E 252	Sodium nitrate Potassium nitrate	Cured meat products Canned meat products Hard, semi-hard and semi-soft cheese Dairy-based cheese analogue Pickled herring and sprat	300	250(14) 50(14) 200(15)
E 280 E 281 E 282 E 283	Propionic acid(16) Sodium propionate(16) Calcium propionate(16) Potassium propionate(16)	Pre-packed sliced bread and rye bread Energy reduced bread Partially baked, pre-packed bread Pre-packed fine bakery wares (including flour confectionery) with a water activity of more than 0.65 Pre-packed Rolls, buns andpitta Christmas puddingPre-packed bread	3000 mg/kg expressed as propionic acid 2000 mg/kg expressed as propionic acid 1000 mg/kg expressed as propionic acid
E 1105	Lysozyme	Ripened cheese	quantum satis

PART D Other antioxidants

EC No.	Name	Food	Maximum level (mg/kg)
E 310 E 311 E 312 E 320 E 321	Propyl gallate Octyl gallate Dodecyl gallate Butylated hydroxyanisole (BHA) Butylated hydroxytoluene (BHT)	Fats and oils for the professional manufacture of heat-treated foods Frying oil and frying fat, excluding olive pomace oil Lard; fish oil; beef, poultry and sheep fat Cake mixes Cereal-based snack foods Milk powder for vending machines Dehydrated soups and broths Sauces Dehydrated meat Processed nuts Seasonings and condiments Pre-cooked cereals Dehydrated granulated potatoes Chewing gum Dietary supplements	200(17) (gallates and BHA, individually or in combination) 100(17) (BHT) both expressed on fat 200 (gallates and BHA, individually or in combination) expressed on fat 25 (gallates and BHA, individually or in combination) 400 (gallates, BHT and BHA, individually or in combination)
E 315 E 316	Erythorbic acid Sodium erythorbate	Semi-preserved and preserved meat products Preserved and semi-preserved fish products Frozen and deep-frozen fish with red skin	500 expressed as erythorbic acid 1500 expressed as erythorbic acid

Regulations 2(1) and 3(5)

SCHEDULE 3 OTHER PERMITTED MISCELLANEOUS ADDITIVES

The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers' instructions.

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 (i) Monosodium phosphate (ii) Disodium phosphate (iii) Trisodium phosphate Potassium phosphates (i) Monopotassium phosphate (ii) Dipotassium phosphate (iii) Tripotassium phosphate Calcium phosphates (i) Monocalcium phosphate (ii) Dicalcium phosphate (iii) Tricalcium phosphate Diphosphates (i) Disodium diphosphate (ii) Trisodium diphosphate (iii) Tetrasodium diphosphate (iv) Dipotassium diphosphate (v) Tetrapotassium diphosphate (vi) Dicalcium diphosphate (vii) Calcium dihydrogen diphosphate Triphosphates (i) Pentasodium triphosphate (ii) 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(18) 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 (i) Sodium polyphosphate (ii) Potassium polyphosphate (iii) Sodium calcium polyphosphate (iv) 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(19) 10 g/kg(20) 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 (i) Sorbitol (ii) Sorbitol syrup Mannitol Isomalt Maltitol (i) Maltitol (ii) 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(21) 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(22) 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(23) 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 (i) Magnesium silicate (ii) Magnesium trisilicate(24) Talc(24) 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(25)
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(26) 2500 mg/kg(26) 10 mg/kg(26) (as flavour enhancer only)
E 959	Neohesperidine DC	Chewing gum with added sugars Margarine Minarine Meat products Fruit jellies Vegetable proteins	150 mg/kg(26) 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(27) Butane(27) Iso-Butane(27)	Garlic flavoured oil spray for producing garlic bread and pizza Vegetable oil pan spray for professional use only	quantum satis

Regulations 2(1), 3(6) and 5(2)

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

Regulations 2(1) and 11(3)

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(28) as amended by Council Directive 67/428/EEC(29) and Council Directive 76/463/EEC(30).

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(31).

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(32).

• 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(33).

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(34) as amended by Article 1.2(a) of Council Directive 82/504/EEC(35).

• 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(36).

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(37).

• 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(38).

• 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.

Regulations 3(2) and (4) and 4(3)

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

• Unprocessed foods

• Honey as defined in Directive 74/409/EEC(39)

• 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(40) 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)

Regulations 3(2) to (4) and 4(3)

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

Food	Additive	Maximum level
Cocoa and chocolate products as defined in Directive 73/241/EEC(41)	E 330 Citric acid E 322 Lecithins E 334 Tartaric acid E 422 Glycerol E 471 Monoand diglycerides of fatty acids E 170 Calcium carbonates E 500 Sodium carbonates E 501 Potassium carbonates E 503 Ammonium carbonates E 504 Magnesium carbonates E 524 Sodium hydroxide E 525 Potassium hydroxide E 526 Calcium hydroxide E 527 Ammonium hydroxide E 528 Magnesium hydroxide E 530 Magnesium oxide E 414 Acacia gum E 440 Pectins	0.5 % quantum satis 0.5% quantum satis 7% on dry matter without fat expressed as potassium carbonates as glazing agents only quantum satis
Fruit juices and nectars as defined in Directive 93/77/EEC(42)	E 300 Ascorbic acid	quantum satis
Pineapple juice as defined in Directive 93/77/EEC	E 296 Malic acid	3 g/l
Nectars as defined in Directive 93/77/EEC	E 330 Citric acid E 270 Lactic acid	5 g/l 5 g/l
Grape juice as defined in Directive 93/77/EEC	E 170 Calcium carbonates E 336 Potassium tartrates	quantum satis
Fruit juices as defined in Directive 93/77/EEC	E 330 Citric acid	3 g/l
Extra jam and extra jelly, as defined in Directive 79/693/EEC	E 270 Lactic acid E 296 Malic acid E 300 Ascorbic acid E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 350 Sodium malates E 440 Pectins E 471 Monoand diglycerides of fatty acids	quantum satis
Jam, jellies and marmalades as defined in Directive 79/693/EEC and other similar fruit spreads including low-calorie products	E 270 Lactic acid E 296 Malic acid E 300 Ascorbic acid E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 350 Sodium malates E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate E 404 Calcium alginate E 406 Agar E 407 Carrageenan E 410 Locust bean gum E 412 Guar gum E 415 Xanthan gum E 418 Gellan gum E 440 Pectins E 509 Calcium chloride E 524 Sodium hydroxide	quantum satis 10 g/kg (individually or in combination) quantum satis
Partially dehydrated and dehydrated milk as defined in Directive 76/118/EEC(43)	E 300 Ascorbic acid E 301 Sodium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 331 Sodium citrates E 332 Potassium citrates E 407 Carrageenan E 500 (ii) Sodium bicarbonate E 501 (ii) Potassium bicarbonate E 509 Calcium chloride	quantum satis
Sterilised, pasteurised and UHT cream, low-calorie cream and pasteurised low-fat cream	E 270 Lactic acid E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates E 400 Alginic acid E 401 Sodium alginate E 402 Potassium alginate E 403 Ammonium alginate E 404 Calcium alginate E 406 Agar E 407 Carrageenan E 410 Locust bean gum E 415 Xanthan gum E 440 Pectins E 460 Celluloses E 461 Methyl cellulose E 463 Hydroxypropyl cellulose E 464 Hydroxypropyl methyl cellulose E 465 Ethyl methyl cellulose E 466 Carboxy methyl cellulose Sodium carboxy methyl cellulose E 471 Monoand diglycerides of fatty acids E 508 Potassium chloride E 509 Calcium chloride E 1404 Oxidised starch E 1410 Monostarch phosphate E 1412 Distarch phosphate E 1413 Phosphated distarch phosphate E 1414 Acetylated distarch phosphate E 1420 Acetylated starch E 1422 Acetylated distarch adipate E 1440 Hydroxy propyl starch E 1442 Hydroxy propyl distarch phosphate E 1450 Starch sodium octenyl succinate	quantum satis
Frozen and deepfrozen unprocessed fruit and vegetables Fruit compote Unprocessed fish, crustaceans and molluscs, including such products frozen and deep-frozen	E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates	quantum satis
Quick-cook rice	E 471 Monoand diglycerides of fatty acids E 472a Acetic acid esters of monoand diglycerides of fatty acids	quantum satis
Non emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils)	E 304 Fatty acid esters of ascorbic acid E 306 Tocopherol-rich extract E 307 Alpha-tocopherol E 308 Gamma-tocopherol E 309 Delta-tocopherol E 322 Lecithins E 471 Monoand diglycerides of fatty acids E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates	quantum satis 30 g/l 10 g/l quantum satis
Refined olive oil, including olive pomace oil	E 307 Alpha-tocopherol	200 mg/l
Ripened cheese	E 170 Calcium carbonates E 504 Magnesium carbonates E 509 Calcium chloride E 575 Glucono-delta-lactone	quantum satis
Mozzarella and whey cheese	E 270 Lactic acid E 330 Citric acid E 575 Glucono-delta-lactone	quantum satis
Canned and bottled fruit and vegetables	E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates E 334 Tartaric acid E 335 Sodium tartrates E 336 Potassium tartrates E 337 Sodium potassium tartrate E 509 Calcium chloride E 575 Glucono-delta-lactone	quantum satis
Gehakt	E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates	quantum satis
Pre-packed preparations of fresh minced meat	E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 330 Citric acid E 331 Sodium citrates E 332 Potassium citrates E 333 Calcium citrates	quantum satis
Bread prepared solely with the following ingredients: wheat-flour, water, yeast or leaven, salt	E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 471 Monoand diglycerides of fatty acids E 472a Acetic acid esters of monoand diglycerides of fatty acids E 472d Tartaric acid esters of monoand diglycerides of fatty acids E 472e Monoand diacetyl tartaric acid esters of monoand diglycerides of fatty acids E 472f Mixed acetic and tartaric acid esters of monoand diglycerides of fatty acids	quantum satis
Pain courant français	E 260 Acetic acid E 261 Potassium acetate E 262 Sodium acetates E 263 Calcium acetate E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 302 Calcium ascorbate E 304 Fatty acid esters of ascorbic acid E 322 Lecithins E 325 Sodium lactate E 326 Potassium lactate E 327 Calcium lactate E 471 Monoand diglycerides of fatty acids	quantum satis
Fresh pasta	E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 322 Lecithins E 330 Citric acid E 334 Tartaric acid E 471 Monoand diglycerides of fatty acids E 575 Glucono-delta-lactone	quantum satis
Wines and sparkling wines and partially fermented grape must	Additives authorised: in accordance with Regulations (EEC) No. 822/87, (EEC) No. 4252/88, (EEC) No. 2332/92 and (EEC) No. 1873/84 and their implementing regulations; 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	pro memoria
Beer	E 270 Lactic acid E 300 Ascorbic acid E 301 Sodium ascorbate E 330 Citric acid E 414 Acacia gum	quantum satis
Foie gras, foie gras entier, blocs de foie gras	E 300 Ascorbic acid E 301 Sodium ascorbate	quantum satis

Regulation 3(7) and (8)

SCHEDULE 8 MISCELLANEOUS ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN

Notes

1.  Formulae and weaning foods for infants and young children may contain E 414 acacia gum (gum arabic) and E 551 silicon dioxide resulting from the addition of nutrient preparations containing not more than 10 g/kg

of each of these substances, as well as E 421 mannitol when used as a carrier for vitamin B 12 (not less than 1 part vitamin B 12 to 1000 parts mannitol).

2.  The maximum levels of use indicated refer to foods ready for consumption prepared following manufacturers' instructions.

PART 1 MISCELLANEOUS ADDITIVES PERMITTED IN INFANT FORMULAE FOR INFANTS IN GOOD HEALTH

Notes

(a) For the manufacture of acidified milks, non-pathogenic L(+)-lactic acid producing cultures may be used.

(b) If more than one of the substances E 322 and E 471 is added to a food, the maximum level established for that food for each of those substances is lowered with that relative part as is present of the other substance in that food.

EC No.	Name	Maximum level
E 270 E 330 E 338	Lactic acid (L(+)-form only) Citric acid Phosphoric acid	quantum satis quantum satis In conformity with the limits set in Annex 1 to Directive 91/321/EEC
E 306 E 307 E 308 E 309	Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocophorol	10 mg/l individually or in combination
E 322 E 471	Lecithins Monoand diglycerides of fatty acids	1 g/l 4 g/l

PART 2 MISCELLANEOUS ADDITIVES PERMITTED IN FOLLOW-ON FORMULAE FOR INFANTS IN GOOD HEALTH

Notes

(a) For the manufacture of acidified milks, non-pathogenic L(+)-lactic acid producing cultures may be used.

(b) If more than one of the substances E 322 and E 471 is added to a food, the maximum level established for that food for each of those substances is lowered with that relative part as is present of the other substance in that food.

(c) If more than one of the substances E 407, E 410 and E 412 is added to a food, the maximum level established for that food for each of those substances is lowered with that relative part as is present of the other substances together in that food.

EC No.	Name	Maximum level
E 270 E 330	Lactic acid (L(+)-form only) Citric acid	quantum satis quantum satis
E 306 E 307 E 308 E 309	Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol	10 mg/l individually or in combination
E 338	Phosphoric acid	In conformity with the limits set in Annex II to Directive 91/321/EEC
E 440	Pectins	5 g/l in acidified follow-on formulae only
E 322 E 471	Lecithins Monoand diglycerides of fatty acids	1 g/l 4 g/l
E 407 E 410 E 412	Carrageenan Locust bean gum Guar gum	0.3 g/l 1 g/l 1 g/l

PART 3 MISCELLANEOUS ADDITIVES PERMITTED IN WEANING FOODS FOR INFANTS AND YOUNG CHILDREN IN GOOD HEALTH

EC No.	Name	Food	Maximum level
E 170 E 260 E 261 E 262 E 263 E 270 E 296 E 325 E 326 E 327 E 330 E 331 E 332 E 333 E 507 E 524 E 525 E 526	Calcium carbonates Acetic acid Potassium acetate Sodium acetates Calcium acetate Lactic acid(44) Malic acid(44) Sodium lactate(44) Potassium lactate(44) Calcium lactate(44) Citric acid Sodium citrates Potassium citrates Calcium citrates Hydrochloric acid Sodium hydroxide Potassium hydroxide Calcium hydroxide	Weaning foods	quantum satis (only for pH adjustment)
E 500 E 501 E 503	Sodium carbonates Potassium carbonates Ammonium carbonates	Weaning foods	quantum satis (only as raising agents)
E 300 E 301 E 302	L-ascorbic acid Sodium L-ascorbate Calcium L-ascorbate	Fruit and vegetable-based drinks, juices and baby foods Fat-containing cereal-based foods including biscuits and rusks	0.3 g/kg 0.2 g/kg individually or in combination, expressed as ascorbic acid
E 304 E 306 E 307 E 308 E 309	L-ascorbyl palmitate Tocopherol-rich extract Alpha-tocopherol Gamma-tocopherol Delta-tocopherol	Fat-containing cereals, biscuits, rusks and baby foods	0.1 g/kg individually or in combination
E 338	Phosphoric acid	Weaning foods	1 g/kg as P2O5 (only for pH adjustment)
E 339 E 340 E 341	Sodium phosphates Potassium phosphates Calcium phosphates	Cereals	1 g/kg individually or in combination, expressed as P2O5
E 322	Lecithins	Biscuits and rusks Cereal-based foods Baby foods	10 g/kg
E 471 E 472a E 472b E 472c	Mono- and diglycerides of fatty acids Acetic acid esters of monoand diglycerides of fatty acids Lactic acid esters of monoand diglycerides of fatty acids Citric acid esters of monoand diglycerides of fatty acids	Biscuits and rusks Cereal-based foods Baby foods	5 g/kg individually or in combination
E 400 E 401 E 402 E 404	Alginic acid Sodium alginate Potassium alginate Calcium alginate	Desserts Puddings	0.5 g/kg individually or in combination
E 410 E 412 E 414 E 415 E 440	Locust bean gum Guar gum Acacia gum (gum arabic) Xanthan gum Pectins	Weaning foods Gluten-free cereal-based foods	10 g/kg individually or in combination 20 g/kg individually or in combination
E 551	Silicon dioxide	Dry cereals	2 g/kg
E 334 E 335 E 336 E 354 E 450a E 575	Tartaric acid(45) Sodium tartrate(45) Potassium tartrate(45) Calcium tartrate(45) Disodium diphosphate Glucono-delta-lactone	Biscuits and rusks	5 g/kg as a residue
E 1404 E 1410 E 1412 E 1413 E 1414 E 1420 E 1422 E 1450	Oxidised starch Monostarch phosphate Distarch phosphate Phosphated distarch phosphate Acetylated distarch phosphate Acetylated starch Acetylated distarch adipate Starch sodium octenyl succinate	Weaning foods	50 g/kg

PART 4 MISCELLANEOUS ADDITIVES PERMITTED IN FOODS FOR INFANTS AND YOUNG CHILDREN FOR SPECIAL MEDICAL PURPOSES

The tables in Parts 1 to 3 of this Schedule are applicable.

Regulation 10(1)

SCHEDULE 9 REVOCATIONS

Column 1	Column 2	Column 3
Regulations revoked	References	Extent of revocation
The Meat (Treatment) Regulations 1964.	S.I. 1964/19.	The whole Regulations.
The Meat (Treatment) (Scotland) Regulations 1964.	S.I. 1964/44.	The whole Regulations.
The Mineral Hydrocarbons in Food Regulations 1966.	S.I. 1966/1073.	In regulation 2(1), the definition of dried fruit.
The Mineral Hydrocarbons in Food (Scotland) Regulations 1966.	S.I. 1966/1263.	In regulation 2(1), the definition of dried fruit.
The Solvents in Food Regulations 1967.	S.I. 1967/1582.	The whole Regulations.
The Solvents in Food (Amendment) Regulations 1967.	S.I. 1967/1939.	The whole Regulations.
The Solvents in Food (Scotland) Regulations 1968.	S.I. 1968/263.	The whole Regulations.
The Specified Sugar Products Regulations 1976.	S.I. 1976/509.	In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted anti-foaming agent”, “permitted emulsifier” and “permitted preservative”.
		In the proviso to regulation 9, paragraph (d).
		Regulation 15.
		Schedule 3.
The Cocoa and Chocolate Products Regulations 1976.	S.I. 1976/541.	In regulation 2(1), the definitions of “permitted acid”, “permitted base” and “permitted emulsifier”.
		In Schedule 2, Part I.
The Cocoa and Chocolate Products (Scotland) Regulations 1976.	S.I. 1976/914.	In regulation 2(1), the definitions of “permitted acid”, “permitted base” and “permitted emulsifier”.
		In Schedule 2, Part I.
The Specified Sugar Products (Scotland) Regulations 1976.	S.I. 1976/946.	In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted anti-foaming agent”, “permitted emulsifier” and “permitted preservative”.
		In the proviso to regulation 9, paragraph (d).
		Regulation 16.
		Schedule 3.
The Fruit Juices and Fruit Nectars Regulations 1977.	S.I. 1977/927.	In regulation 2(1), the definitions of “anti-foaming agent”, “permitted acid”, “permitted anti-foaming agent” and “permitted preservative”.
		Regulation 2(3).
		Regulation 6(a).
		Regulation 17.
		In Part III of Schedule 2, in the definition of “sucrose solution”, paragraph (e).
		Schedule 3.
The Condensed Milk and Dried Milk Regulations 1977.	S.I. 1977/928.	In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted antioxidant” and “permitted emulsifier”.
		Regulation 2(5).
		Regulation 5A(e).
		Schedule 2.
The Fruit Juices and Fruit Nectars (Scotland) Regulations 1977.	S.I. 1977/1026.	In regulation 2(1), the definitions of “anti-foaming agent”, “permitted acid”, “permitted anti-foaming agent” and “permitted preservative”.
		Regulation 2(3).
		Regulation 6(a).
		Regulation 18.
		In Part III of Schedule 2, in the definition of “sucrose solution”, paragraph (e).
		Schedule 3.
The Condensed Milk and Dried Milk (Scotland) Regulations 1977.	S.I. 1977/1027.	In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted antioxidant” and “permitted emulsifier”.
		Regulation 2(5).
		Regulation 5A(e).
		Schedule 2.
The Antioxidants in Food Regulations 1978.	S.I. 1978/105.	The whole Regulations.
The Antioxidants in Food (Scotland) Regulations 1978.	S.I. 1978/492.	The whole Regulations.
The Coffee and Coffee Products Regulations 1978.	S.I. 1978/1420.	In regulation 2(1), the definitions of “permitted anti-caking agent” and “permitted preservative”.
		Regulation 5A(d).
		Regulation 14.
The Coffee and Coffee Products (Scotland) Regulations 1979.	S.I. 1979/383.	In regulation 2(1), the definitions of “permitted anti-caking agent” and “permitted preservative”.
		Regulation 5A(d).
		Regulation 15.
The Antioxidants in Food (Amendment) Regulations 1980.	S.I. 1980/1831.	The whole Regulations.
The Solvents in Food (Amendment) Regulations 1980.	S.I. 1980/1832.	The whole Regulations.
The Miscellaneous Additives in Food Regulations 1980.	S.I. 1980/1834.	The whole Regulations.
The Antioxidants in Food (Scotland) (Amendment) Regulations 1980.	S.I. 1980/1886.	The whole Regulations.
The Solvents in Food (Scotland) (Amendment) Regulations 1980.	S.I. 1980/1887.	The whole Regulations.
The Miscellaneous Additives in Food (Scotland) Regulations 1980.	S.I. 1980/1889.	The whole Regulations.
The Jam and Similar Products Regulations 1981.	S.I. 1981/1063.	Regulation 11(5).
		Regulation 12(2).
		In regulation 12(2C), the words “Subject to paragraph (2D) of this regulation,”.
		Regulation 12(2D) and (3).
		In regulation 14(1) and (2), the figure “, II”.
		Regulation 15.
		In Schedule 1, in entry 13 relating to mincemeat, in column 2, paragraph (c).
		Schedule 2, Part II.
		In Schedule 2, Part III, in the heading the words “, other than preservatives,” and all the entries following the entry for edible oils and fats, except the entry for liquid pectin.
		The Note to Schedule 2.
		Schedule 3.
		In Schedule 4, paragraph (e).
The Jam and Similar Products (Scotland) Regulations 1981.	S.I. 1981/1320.	Regulation 11(5).
		Regulation 12(2).
		In regulation 12(2C), the words “Subject to paragraph (2D) of this regulation,”.
		Regulation 12(2D) and (3).
		In regulation 14(1) and (2), the figure “, II”.
		Regulation 15.
		In Schedule 1, in entry 13 relating to mincemeat, in column 2, paragraph (c).
		Schedule 2, Part II.
		In Schedule 2, Part III, in the heading the words “, other than preservatives,” and all the entries following the entry for edible oils and fats, except the entry for liquid pectin.
		The Note to Schedule 2.
		Schedule 3.
		In Schedule 4, paragraph (e).
The Miscellaneous Additives in Food (Amendment) Regulations 1982.	S.I. 1982/14.	The whole Regulations.
The Cocoa and Chocolate Products (Amendment) Regulations 1982.	S.I. 1982/17.	Regulation 2(5).
		The Schedule.
The Cocoa and Chocolate Products (Scotland) (Amendment) Regulations 1982.	S.I. 1982/108.	Regulation 2(5).
		The Schedule.
The Miscellaneous Additives in Food (Scotland) (Amendment) Regulations 1982.	S.I. 1982/515.	The whole Regulations.
The Fruit Juices and Fruit Nectars (Amendment) Regulations 1982.	S.I. 1982/1311.	Regulation 8.
The Fruit Juices and Fruit Nectars (Scotland) (Amendment) Regulations 1982.	S.I. 1982/1619.	Regulation 8.
The Food (Revision of Penalties) Regulations 1982.	S.I. 1982/1727.	In Schedule 1, the references to the Meat (Treatment) Regulations 1964, the Solvents in Food Regulations 1967, the Antioxidants in Food Regulations 1978 and the Miscellaneous Additives in Food Regulations 1980.
The Food and Drugs (Scotland) Act 1956 (Transfer and Enforcement Functions) Regulations 1983.	S.I. 1983/270.	In Schedule 2, the references to the Antioxidants in Food (Scotland) Regulations 1978 and the Miscellaneous Additives in Food (Scotland) Regulations 1980.
		In Schedule 3, the references to the Meat Treatment (Scotland) Regulations 1964 and the Solvents in Food (Scotland) Regulations 1968.
The Meat Products and Spreadable Fish Products Regulations 1984.	S.I. 1984/1566.	In regulation 2(1), in the definition of “additive”, the words from “in so far as their use” to the end.
The Meat Products and Spreadable Fish Products (Scotland) Regulations 1984.	S.I. 1984/1714.	In regulation 2(1), in the definition of “additive”, the words from “in so far as their use” to the end.
The Food (Revision of Penalties) Regulations 1985.	S.I. 1985/67.	In Part I of the Schedule, the references to the Meat (Treatment) Regulations 1964, the Solvents in Food Regulations 1967, the Antioxidants in Food Regulations 1978 and the Miscellaneous Additives in Food Regulations 1980.
The Food (Revision of Penalties and Mode of Trial) (Scotland) Regulations 1985.	S.I. 1985/1068.	In Schedule 1, the references to the Meat Treatment (Scotland) Regulations 1964, the Solvents in Food (Scotland) Regulations 1968, the Antioxidants in Food (Scotland) Regulations 1978 and the Miscellaneous Additives in Food (Scotland) Regulations 1980.
The Condensed Milk and Dried Milk (Amendment) Regulations 1986.	S.I. 1986/2299.	Regulation 2(b).
The Condensed Milk and Dried Milk (Scotland) (Amendment) Regulations 1987.	S.I. 1987/26.	Regulation 2(b).
The Preservatives in Food Regulations 1989.	S.I. 1989/533.	The whole Regulations.
The Preservatives in Food (Scotland) Regulations 1989.	S.I. 1989/581.	The whole Regulations.
The Emulsifiers and Stabilisers in Food Regulations 1989.	S.I. 1989/876.	The whole Regulations.
The Emulsifiers and Stabilisers in Food (Scotland) Regulations 1989.	S.I. 1989/945.	The whole Regulations.
The Preservatives in Food (Scotland) (Amendment) Regulations 1989.	S.I. 1989/2216.	The whole Regulations.
The Preservatives in Food (Amendment) Regulations 1989.	S.I. 1989/2287.	The whole Regulations.
The Jam and Similar Products (Amendment) Regulations 1990.	S.I. 1990/2085.	Regulation 7(1) and (3).
		Regulation 8(a) and (e).
		Regulation 11(b).
The Jam and Similar Products (Scotland) (Amendment) Regulations 1990.	S.I. 1990/2180.	Regulation 7(1) and (3).
		Regulation 8(a) and (e).
		Regulation 11(b).
The Fruit Juices and Fruit Nectars (England, Wales and Scotland) (Amendment) Regulations 1991.	S.I. 1991/1284.	Regulation 6(a).
		Regulation 8.
The Food Safety (Exports) Regulations 1991.	S.I. 1991/1476.	In Part I of Schedule 1, the references to the Solvents in Food Regulations 1967, the Antioxidants in Food Regulations 1978, the Miscellaneous Additives in Food Regulations 1980, the Preservatives in Food Regulations 1989 and the Emulsifiers and Stabilisers in Food Regulations 1989.
		In Schedule 2, the references to the Solvents in Food (Scotland) Regulations 1968, the Antioxidants in Food (Scotland) Regulations 1978, the Miscellaneous Additives in Food (Scotland) Regulations 1980, the Preservatives in Food (Scotland) Regulations 1989 and the Emulsifiers and Stabilisers in Food (Scotland) Regulations 1989.
The Antioxidants in Food (Amendment) Regulations 1991.	S.I. 1991/2540.	The whole Regulations.
The Emulsifiers and Stabilisers in Food (Amendment) Regulations 1992.	S.I. 1992/165.	The whole Regulations.
The Food Additives Labelling Regulations 1992.	S.I. 1992/1978.	Regulation 8(2), (3) and (5).
		Regulation 9(2), (3) and (5).
The Emulsifiers and Stabilisers in Food (Amendment) Regulations 1993.	S.I. 1993/1161.	The whole Regulations.

(1)

OJ No. L149,14.6.91, pp. 1-9.

(2)

OJ No. L84, 27.3.87, p.1.

(3)

In edible parts.

(4)

OJ No. L205, 13.8.79, p.5.

(5)

OJ No. L356, 27.12.73, p.71.

(6)

OJ No. L373, 31.12.88, p.59.

(7)

OJ No. L231, 13.8.92, p.1.

(8)

OJ No. L176, 3.7.84, p.6.

(9)

OJ No. L54, 5.3.79, p.1.

(10)

This substance may be present naturally in certain cheeses as a result of fermentation processes.

(11)

When labelled `for food use', nitrite may only be sold in a mixture with salt or a salt substitute.

(12)

Expressed as NaNO₂.

(13)

Residual amount at point of sale to the final consumer, expressed as NaNO₂.

(14)

Expressed as NaNO₃.

(15)

Residual amount nitrite formed from nitrate included, expressed as NaNO₂.

(16)

Propionic acid and its salts may be present in certain fermented products resulting from the fermentation process following good manufacturing practice.

(17)

When combinations of gallates, BHA and BHT are used, the individual levels must be reduced proportionally.

(18)

E 338 only.

(19)

E 341 (ii) only.

(20)

E 341 (iii) only.

(21)

OJ No. L228, 16.8.73, p.23.

(22)

E 493 only.

(23)

E 492 only.

(24)

Asbestos free.

(25)

E 553b only.

(26)

If E 950, E 951, E 957 and E 959 are used in combination in chewing gum, the maximum level for each is reduced proportionally.

(27)

Authorised until 31 December 1997 in accordance with Article 5 of Directive 89/107/EEC pending consideration for inclusion in Directive 95/2/EC.

(28)

OJ No. L22, 9.2.65, p.373/65 (OJ/SE 1965-66 p.25).

(29)

OJ No. L148, 11.7.67, p.148/10 (OJ/SE 1967 p.178).

(30)

OJ No. L126, 14.5.76, p.33.

(31)

OJ No. L352, 13.12.86, p.45.

(32)

OJ No. L223, 14.8.78, p.30.

(33)

OJ No. L297, 23.10.82, p.31.

(34)

OJ No. L223, 14.8.78, p.7.

(35)

OJ No. L230, 5.8.82, p.35.

(36)

OJ No. L326, 24.11.90, p.58.

(37)

OJ No. L178, 28.7.95, p.1.

(38)

OJ No. L55, 29.2.92, p.96.

(39)

OJ No. L221, 12.8.74, p.10.

(40)

OJ No. L229, 30.8.80, p.1.

(41)

Cocoa and chocolate products energy-reduced or with no added sugars are not covered by Schedule 7.

(42)

OJ No. L224, 30.9.93, p.23.

(43)

OJ No. L24, 30.1.76, p.49.

(44)

L(+)-form only.

(45)

L(+)-form only.