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Miscellaneous Food Additives Regulations (Northern Ireland) 1996

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

SCHEDULE 1Miscellaneous 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 at quantum satis in 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 260Acetic acid
E 261Potassium acetate
E 262

Sodium acetates

(i)

Sodium acetate

(ii)

Sodium hydrogen acetate (sodium diacetate)

E 263Calcium acetate
E 270Lactic acid
E 290Carbon dioxide
E 296Malic acid
E 300Ascorbic acid
E 301Sodium ascorbate
E 302Calcium ascorbate
E 304

Fatty acid esters of ascorbic acid

(i)

Ascorbyl palmitate

(ii)

Ascorbyl stearate

E 306Tocopherol-rich extract
E 307Alpha-tocopherol
E 308Gamma-tocopherol
E 309Delta-tocopherol
E 322Lecithins
E 325Sodium lactate
E 326Potassium lactate
E 327Calcium lactate
E 330Citric 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 334Tartaric acid (L(+)–)
E 335

Sodium tartrates

(i)

Monosodium tartrate

(ii)

Disodium tartrate

E 336

Potassium tartrates

(i)

Monopotassium tartrate

(ii)

Dipotassium tartrate

E 337Sodium potassium tartrate
E 350

Sodium malates

(i)

Sodium malate

(ii)

Sodium hydrogen malate

E 351Potassium malate
E 352

Calcium malates

(i)

Calcium malate

(ii)

Calcium hydrogen malate

E 354Calcium tartrate
E 380Triammonium citrate
E 400Alginic acid
E 401Sodium alginate
E 402Potassium alginate
E 403Ammonium alginate
E 404Calcium alginate
E 406Agar
E 407Carrageenan
E 410Locust bean gum
E 412Guar gum
E 413Tragacanth
E 414Acacia gum (gum arabic)
E 415Xanthan gum
E 417Tara gum
E 418Gellan gum
E 422Glycerol
E 440

Pectins

(i)

pectin

(ii)

amidated pectin

E 460

Cellulose

(i)

Microcrystalline cellulose

(ii)

Powdered cellulose

E 461Methyl cellulose
E 463Hydroxypropyl cellulose
E 464Hydroxypropyl methyl cellulose
E 465Ethyl methyl cellulose
E 466Carboxy methyl cellulose Sodium carboxy methyl cellulose
E 470aSodium, potassium and calcium salts of fatty acids
E 470bMagnesium salts of fatty acids
E 471Mono- and diglycerides of fatty acids
E 472aAcetic acid esters of mono- and diglycerides of fatty acids
E 472bLactic acid esters of mono- and diglycerides of fatty acids
E 472cCitric acid esters of mono- and diglycerides of fatty acids
E 472dTartaric acid esters of mono- and diglycerides of fatty acids
E 472eMono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids
E 472fMixed acetic and tartaric acid esters of mono- and 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 507Hydrochloric acid
E 508Potassium chloride
E 509Calcium chloride
E 511Magnesium chloride
E 513Sulphuric acid
E 514

Sodium sulphates

(i)

Sodium sulphate

(ii)

Sodium hydrogen sulphate

E 515

Potassium sulphates

(i)

Potassium sulphate

(ii)

Potassium hydrogen sulphate

E 516Calcium sulphate
E 524Sodium hydroxide
E 525Potassium hydroxide
E 526Calcium hydroxide
E 527Ammonium hydroxide
E 528Magnesium hydroxide
E 529Calcium oxide
E 530Magnesium oxide
E 570Fatty acids
E 574Gluconic acid
E 575Glucono-delta-lactone
E 576Sodium gluconate
E 577Potassium gluconate
E 578Calcium gluconate
E 640Glycine and its sodium salt
E 938Argon
E 939Helium
E 941Nitrogen
E 942Nitrous oxide
E 948Oxygen
E 1200Polydextrose
E 1404Oxidised starch
E 1410Monostarch phosphate
E 1412Distarch phosphate
E 1413Phosphated distarch phosphate
E 1414Acetylated distarch phosphate
E 1420Acetylated starch
E 1422Acetylated distarch adipate
E 1440Hydroxy propyl starch
E 1442Hydroxy propyl distarch phosphate
E 1450Starch sodium octenyl succinate

Regulations 2(1) and 3(5)

SCHEDULE 2Conditionally Permitted Preservatives and Antioxidants

Part ASorbates, benzoates and p-hydroxybenzoates

EC No.NameAbbreviation
a

(1) Benzoic acid may be present in certain fermented products resulting from the fermentation process following good manufacturing practice.

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 manfacturers' instructions.

E 200Sorbic acidSa
E 202Potassium sorbateSa
E 203Calcium sorbateSa
E 210Benzoic acidBaa
E 211Sodium benzoateBaa
E 212Potassium benzoateBaa
E 213Calcium benzoateBaa
E 214Ethyl p-hydroxybenzoatePHB
E 215Sodium ethyl p-hydroxybenzoatePHB
E 216Propyl p-hydroxybenzoatePHB
E 217Sodium propyl p-hydroxybenzoatePHB
E 218Methyl p-hydroxybenzoatePHB
E 219Sodium methyl p-hydroxybenzoatePHB
Maximum level (mg/kg or mg/l as appropriate)
FoodSaBaPHBSa + BaSa + PHBSa + Ba + BHB
Wine-based flavoured drinks including products covered by Regulation (EEC) No. 1601/91(1)200
Non-alcoholic flavoured drinks (excluding dairy-based drinks)300150250 Sa + 150 Ba
Liquid tea concentrates and liquid fruit and herbal infusion concentrates600
Grape Juice, unfermented, for sacramental use2000
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 . . . Saft500200
Alcohol-free beer in keg200
Mead Spirits with less than 15% alcohol by volume200 200200400
Fillings of ravioli and similar products1000
Low-sugar jams, jellies, marmalades and similar low calorie or sugar-free products and other fruit-based spreads;Mermeladas5001000
Candied, crystallised and glacé fruit and vegetablesMermeladas1000
Dried fruit1000Mermeladas
Frugtgrød and Rote Grütze1000500
Fruit and vegetable preparations including fruit-based sauces, excluding purée, mousse, compote, salads and similar products, canned or bottled1000
Vegetables in vinegar, brine or oil (excluding olives)2000
Potato dough and pre-fried potato slices2000
Gnocchi1000
Polenta200
Olives and olive-based preparations1000
Jelly coatings of meat products (cooked, cured or dried); Paté1000
Surface treatment of dried meat productsquantum satis
Semi-preserved fish products including fish roe products2000
Salted, dried fish200
Shrimps, cooked2000
Crangon crangon and Crangon vulgaris, cooked6000
Cheese, pre-packed, sliced1000
Unripened cheese1000
Processed cheese2000
Layered cheese and cheese with added foods1000
Non-heat-treated dairy-based deserts300
Curdled milk1000
Liquid egg (white, yolk or whole egg)5000
Dehydrated, concentrated, frozen and deep-frozen egg products1000
Pre-packed sliced bread and rye-bread2000
Partially baked, pre-packed bakery wares intended for retail sale2000
Fine bakery wares with a water activity of more than 0.652000
Cereal- or potato-based snacks and coated nuts1000 (max. 300 PHB)
Batters2000
Confectionery (excluding chocolate)1500 (max. 300 PHB)
Chewing gum1500
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 more1000
Fat emulsions with a fat content less than 60%2000
Emulsified sauces with a fat content of 60% or more1000
Emulsified sauces with a fat content less than 60%2000
Non-emulsified sauces1000
Prepared salads1500
Mustard1000
Seasonings and condiments1000
Liquid soups and broths (excluding canned)500
Aspic1000500
Liquid dietary food supplements2000
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 meal1500

Part BSulphur 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 220Sulphur dioxide
E 221Sodium sulphite
E 222Sodium hydrogen sulphite
E 223Sodium metabisulphite
E 224Potassium metabisulphite
E 226Calcium sulphite
E 227Calcium hydrogen sulphite
E 228Potassium hydrogen sulphite
FoodMaximum level (mg/kg or mg/l as appropriate) expressed as SO2
Burger meat with a minimum vegetable and/or cereal content of 4%450
Breakfast sausages Longaniza fresca and Butifarra fresca450 450
Dried salted fish of the ‘Gadidae' species200
Cruscaceans and cephalopods
— fresh, frozen and deep-frozen crustaceans, penaeidae solenceridae, aristeidae family:150(3)
— up to 80 units150(3)
— between 80 and 120 units200(3)
— over 120 units300(3)
— cooked50(3)
Dry biscuit50
Starches (excluding starches for weaning foods, follow-on furmulae and infant formulae)50
Sago30
Pearl barley30
Dehydrated granulated potatoes400
Cereal- and potato-based snacks50
Peeled potatoes50
Processed potatoes (including frozen and deep-frozen potatoes)100
Potato dough100
White vegetables, dried400
White vegetables, processed (including frozen and deep-frozen white vegetables)50
Dried ginger150
Dried tomatoes200
Horseradish pulp800
Onion, garlic and shallot pulp300
Vegetables and fruits in vinegar, oil or brine (except olives and golden peppers in brine)100
Golden peppers in brine500
Processed mushrooms (including frozen mushrooms)50
Dried mushrooms100
Dried fruits
— apricots, peaches, grapes, prunes and figs2000
— bananas1000
— apples and pears600
— other (including nuts in shell)500
Dried coconut50
Candied, crystallised or glacé fruit, vegetables, angelica and citcus peel100
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 products50
Jams, jellies and marmalades made with sulphited fruit100
Fruit-based pie fillings100
Citrus-juice-based seasonings200
Concentrated grape juice for home wine-making2000
Mostarda di frutta100
Jellying fruit extract, liquid pectin for sale to the final consumer800
Bottled whiteheart cherries, rehydrated dried fruit and lychees100
Bottled, sliced lemon250
Sugars as defined in Directive 73/437/EEC(5) except glucose syrup, whether or not dehydrated15
Glucose syrup, whether or not dehydrated20
Treacle and molasses70
Other sugars40
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 establishments50
Lime and lemon juice350
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 groselha250
Non-alcoholic flavoured drinks containing fruit juice20 (carry-over from concentrates only)
Non-alcoholic flavoured drinks containing at least 235 g/l glucose syrup50
Grape juice, unfermented, for sacramental use70
Glucose-syrup-based confectionery50 (carry-over from the glucose syrup only)
Beer including low-alcohol and alcohol-free beer20
Beer with a second fermentation in the cask50
Winesin 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 wine200
Made wine260
Cider, perry, fruit wine, sparkling fruit wine (including alcohol-free products)200
Mead200
Fermentation vinegar170
Mustard, excluding Dijon mustard Dijon mustard250 500
Gelatin50
Vegetable- and cereal-protein-based meat, fish and crustacean analogues200

Part COther preservatives

EC No.NameFoodMaximum level
E 230Biphenyl, diphenylSurface treatment of citrus fruits70 mg/kg
E 231Orthophenyl phenolSurface treatment of citrus fruits12 mg/kg individually or in combination expressed as orthophenyl phenol
E 232Sodium orthophenyl phenolSurface treatment of citrus fruits12 mg/kg individually or in combination expressed as orthophenyl phenol
E 233Thiabendazole

Surface treatment of:

  • citrus fruit

  • bananas

6 mg/kg

3 mg/kg

E 234Nisin(10)Semolina and tapioca puddings and similar products3 mg/kg
Ripened cheese and processed cheese12.5 mg/kg
Clotted cream10 mg/kg
E 235Natamycin

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 239Hexamethylene tetramineProvolone cheese25 mg/kg residual amount, expressed as formaldehyde
E 242Dimethyl dicarbonate

Non-alcoholic flavoured drinks

Alcohol-free wine

Liquid-tea concentrate

250 mg/l ingoing amount, residues not detectable
E 284Boric acidSturgeons' eggs (Caviar)4g/kg expressed as boric acid
E 285Sodium tetraborate (borax)Sturgeons' eggs (Caviar)4g/kg expressed as boric acid
EC No.NameFoodIndicative ingoing amount mg/kgResidual amount mg/kg
mg/kgmg/kg

E 249

E 250

Potassium nitrite(11)

Sodium nitrite(11)

Non-heat-treated, cured, dried meat products150(12)50(13)

Other cured meat products

Canned meat products

Foie gras, foie gras entier, blocs de foie gras

150(12)100(13)
Cured bacon175(13)

E 251

E 252

Sodium nitrate

Potassium nitrate

Cured meat products

Canned meat products

300250((14)

Hard, semi-hard and semi-soft cheese

Dairy-based cheese analogue

50(14)
Pickled herring and sprat200(15)
EC No.NameFoodMaximum level
E 280Propionic acid(16)
E 281Sodium propionate(16)
E 282Calcium propionate(16)
E 283Potassium propionate(16)Pre-packed sliced bread and rye bread3000 mg/kg expressed as propionic acid

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 and pitta

2000 mg/kg expressed as propionic acid

Christmas pudding

Pre-packed bread

1000 mg/kg expressed as propionic acid
E 1105LysozymeRipened cheesequantum satis

Part DOther antioxidants

EC No.NameFoodMaximum 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

200(17) (gallates and BHA, individually or in combination)

100(17) (BHT)

both expressed on fat

Cake mixes200 (gallates and BHA, individually or in combination
Cereal-based snack foods
Milk powder for vending machines
Dehydrated soups and brothsexpressed on fat
Sauces
Dehydrated meat
Processed nuts
Seasonings and condiments
Pre-cooked cereals
De-hydrated granulated potatoes25 (gallates and BHA, individually or in combination)

Chewing gum

Dietary supplements

400 (gallates, BHT and BHA, individually or in combination)
E 315Erythorbic acidSemi-preserved and preserved meat products500 expressed as erythorbic acid
E 315Erythorbic acid

Preserved and semi-preserved fish products

Frozen and deep-frozen fish with red skin

1500 expressed as erythorbic acid
E 316Sodium erythorbateSemi-preserved and preserved meat products500 expressed as erythorbic acid
E 316Sodium erythorbate

Preserved and semi-preserved fish products

Frozen and deep-frozen fish with red skin

1500 expressed as erythorbic acid

Regulations 2(1) and 3(5)

SCHEDULE 3Other Permitted Miscellaneous Additives

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

EC No.NameFoodMaximum level
E 297Fumaric 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 wares2.5 g/kg
Sugar confectionery1 g/kg
Gel-like desserts; Fruit-flavoured desserts; Dry-powdered dessert mixes4 g/kg
Instant powders for fruit based drinks1 g/l
Instant tea powder1 g/l
Chewing Gum2 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

Phosphoric acid
  • E 339

Sodium phosphates

(i)Monosodium phosphate

(ii)Disodium phosphate

(iii)Trisodium phosphate

  • E 340

Potassium phosphates

(i)Monopotassium phosphate

(ii)Dipotassium phosphate

(iii)Tripotassium phosphate

  • E 341

Calcium phosphates

(i)Monocalcium phosphate

(ii)Dicalcium phosphate

(iii)Tricalcium phosphate

  • E 450

Diphosphates

(i)Disodium diphosphate

(ii)Trisodium diphosphate

(iii)Tetrasodium diphosphate

(iv)Dipotassium diphosphate

(v)Tetrapotassium diphosphate

(vi)Dicalcium diphosphate

(vii)Calcium dihydrogen diphosphate

  • E 451

Triphosphates

(i)Pentasodium triphosphate

(ii)Pentapotassium triphosphate

  • E 452

Polyphosphates

(i)Sodium polyphosphate

(ii)Potassium polyphosphate

(iii)Sodium calcium polyphosphate

(iv)Calcium polyphosphates

Non-alcoholic flavoured drinks700 mg/l(18)
Sterilised and UHT milk1 g/l
Partly dehydrated milk with less than 28% solids1 g/kg
Partly dehydrated milk with more than 28% solids1.5 g/kg
Dried milk and dried skimmed milk2.5 g/kg
Pasteurised, sterilised and UHT creams5 g/kg
Whipped cream and vegetable fat analogues5 g/kg
Unripened cheese (except Mozzarella)2 g/kg
Processed cheese and processed cheese analogues20 g/kg
Meat products5 g/kg
Sport drinks and prepared table waters0.5 g/l
Dietary supplementsquantum satis
Salt and its substitutes10 g/kg
Vegetable protein drinks20 g/l
Beverage whiteners30 g/kg
Beverage whiteners for vending machines50 g/kg
Edible ices1 g/kg
Desserts3 g/kg
Dry powdered dessert mixes7 g/kg
Fine bakery wares20 g/kg
Flour2.5 g/kg
Flour, self-raising20 g/kg
Soda bread20 g/kg
Liquid egg (white, yolk or whole egg)10 g/kg
Sauces5 g/kg
Soups and broths3 g/kg
Tea and herbal infusions2 g/l
Cider and perry2 g/l
Chewing gumquantum satis(19)
Dried powdered foods10 g/kg(20)
Chocolate and malt dairy-based drinks2 g/l
Alcoholic drinks (excluding wine and beer)1 g/l
Breakfast cereals5 g/kg
Snacks5 g/kg
Surimi1 g/kg
Fish and crustacean paste5 g/kg
Toppings (syrups for pancakes, flavoured syrups for milkshakes and ice cream; similar products)3 g/kg
Special formulae for particular nutritional uses5 g/kg
Glazings for meat and vegetable products4 g/kg
Sugar confectionery5 g/kg
Icing sugar10 g/kg
Noodles2 g/kg
Batters5 g/kg
Fillets of unprocessed fish, frozen and deep-frozen5 g/kg
Frozen and deep-frozen crustacean products5 g/kg
Processed potato products (including frozen, deep-frozen, chilled and dried processed products)5 g/kg
E 431Polyoxyethylene (40) stearate(pro memoria) Wine in accordance with Reglation (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 353Metatartaric acidE 353Wine 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
Made wine100 mg/l
E 355Adipic acid
E 356Sodium adipate
E 357Potassium adipateFillings and toppings for fine bakery wares2 g/kg
Dry powdered dessert mixes1 g/kg
Gel-like desserts6 g/kg
Fruit-flavoured desserts1 g/kg
Powders for home preparation of drinks10 g/l expressed as adipic acid
E 363Succinic acidDesserts6 g/kg
Soups and broths5 g/kg
Powders for home preparation of drinks3 g/l
E 385Calcium disodium ethylene diamine tetra-acetate (Calcium disodium EDTA)Emulsified sauces75 mg/kg
Canned and bottled pulses, legumes, mushrooms and artichokes250 mg/kg
Canned and bottled crustaceans and molluscs75 mg/kg
Canned and bottled fish75 mg/kg
Minarine100 mg/kg
Frozen and deep-frozen crustaceans75 mg/kg
E 405Propane-1,2-diol alginateFat emulsions3 g/kg
Fine bakery wares2 g/kg
Fillings, toppings and coatings for fine bakery wares and desserts5 g/kg
Sugar confectionery1.5 g/kg
Water-based edible ices3 g/kg
Cereal- and potato-based snacks3 g/kg
Sauces8 g/kg
Beer100 mg/l
Chewing gum5 g/kg
Fruit and vegetable preparations5 g/kg
Non-alcoholic flavoured drinks300 mg/l
Emulsified liqueur10 g/l
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal1.2 g/kg
Dietary food supplements1 g/kg
E 416Karaya gumCereal- and potato-based snacks5 g/kg
Nut coatings10 g/kg
Fillings, toppings and coatings for fine bakery wares5 g/kg
Desserts6 g/kg
Emulsified sauces10 g/kg
Egg-based liqueurs10 g/l
Dietary food supplementsquantum satis
Chewing gum5 g/kg
E 420

Sorbitol

(i)

Sorbitol

(ii)

Sorbitol syrup

E 421Mannitol
E 953Isomalt
E 965

Maltitol

(i)

Maltitol

(ii)

Maltitol syrup

E 966Lactitol
E 967Xylitol

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 432Polyoxyethylene sorbitan monolaurate (polysorbate 20)
E 433Polyoxyethylene sorbitan monooleate (polysorbate 80)
E 434Polyoxyethylene sorbitan monopalmitate (polysorbate 40)
E 435Polyoxyethylene sorbitan monostearate (polysorbate 60)
E 436Polyoxyethylene sorbitan tristearate (polysorbate 65)Fine bakery wares3 g/kg
Fat emulsions for baking purposes10 g/kg
Milk and cream analogues5 g/kg
Edible ices1 g/kg
Desserts3 g/kg
Sugar confectionery1 g/kg
Emulsified sauces5 g/kg
Soups1 g/kg
Chewing gum5 g/kg
Dietary food supplementsquantum satis
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal1 g/kg Individually or in combination
E 442Ammonium phosphatidesCocoa and chocolate products as defined in Directive 73/241/EEC(21)10 g/kg
Cocoa-based confectionery10 g/kg
E 444Sucrose acetate isobutyrateNon-alcoholic flavoured cloudy drinks300 mg/l
E 445Glycerol esters of wood rosinsNon-alcoholic flavoured cloudy drinks100 mg/l
E 473Sucrose esters of fatty acids
E 474SucroglyceridesCanned liquid coffee1 g/l
Heat-treated meat products5 g/kg (on fat)
Fat emulsions for baking purposes10 g/kg
Fine bakery wares10 g/kg
Beverage whiteners20 g/kg
Edible ices5 g/kg
Sugar confectionery5 g/kg
Desserts5 g/kg
Sauces10 g/kg
Soups and broths2 g/kg
Fresh fruits, surface treatmentquantum satis
Non-alcoholic aniseed-based drinks5 g/l
Non-alcoholic coconut and almond drinks5 g/l
Spirituous beverages (excluding wine and beer)5 g/l
Powders for the preparation of hot beverages10 g/l
Dairy-based drinks5 g/l
Dietary food supplementsquantum satis
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal5 g/kg
Chewing gum10 g/kg Individually or in combination
E 475Polyglycerol esters of fatty acidsFine bakery wares10 g/kg
Emulsified liqueurs5 g/l
Egg products1 g/kg
Beverage whiteners0.5 g/kg
Chewing gum5 g/kg
Fat emulsions5 g/kg
Milk and cream analogues5 g/kg
Sugar confectionery2 g/kg
Desserts2 g/kg
Dietary food supplementsquantum satis
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal5 g/kg
Granola-type breakfast cereals10 g/kg
E 476Polyglycerol polyricinoleateLow and very low fat spreads and dressings4 g/kg
Cocoa-based confectionery, including chocolate5 g/kg
E 477Propane-1,2-diol esters of fatty acidsFine bakery wares5 g/kg
Fat emulsions for baking purposes10 g/kg
Milk and cream analogues5 g/kg
Beverage whiteners1 g/kg
Edible ices3 g/kg
Sugar confectionery5 g/kg
Desserts5 g/kg
Whipped dessert toppings other than cream30 g/kg
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal1 g/kg
E 479bThermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acidsFat emulsion for frying purposes5 g/kg
E 481Sodium stearoyl-2-lactylate
E 482Calcium stearoyl-2-lactylateFine bakery wares5 g/kg
Quick-cook rice4 g/kg
Breakfast cereals5 g/kg
Emulsified liqueur8 g/l
Spirits with less than 15% alcohol by volume8 g/l
Cereal-based snacks2 g/kg
Chewing gum2 g/kg
Fat emulsions10 g/kg
Desserts5 g/kg
Sugar confectionery5 g/kg
Beverage whiteners3 g/kg
Cereal- and potato-based snacks5 g/kg
Minced and diced canned meat products4 g/kg
Powders for the preparation of hot beverages2 g/l
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal2 g/kg
Bread (except that referred to in Schedule 7)3 g/kg
Mostarda di frutta2 g/kg Individually or in combination
E 483Stearyl tartrateBakery wares (except breads referred to in Schedule 7)4 g/kg
Desserts5 g/kg
E 491Sorbitan monostearate
E 492Sorbitan tristearate
E 493Sorbitan monolaurate
E 494Sorbitan monooleate
E 495Sorbitan monopalminateFine bakery wares10 g/kg
Toppings and coatings for fine bakery wares5 g/kg
Jelly marmalade25 mg/kg(22)
Fat emulsions10 g/kg
Milk and cream analogues5 g/kg
Beverage whiteners5 g/kg
Liquid tea concentrates and liquid and herbal infusions concentrates0.5 g/l
Edible ices0.5 g/kg
Desserts5 g/kg
Sugar confectionery5 g/kg
Cocoa-based confectionery, including chocolate10 g/kg(23)
Emulsified sauces5 g/kg
Dietary food supplementsquantum satis
Yeast for bakingquantum satis
Chewing gum5 g/kg
Dietetic foods intended for special medical purposes — Dietetic formulae for weight control intended to replace total daily food intake or an individual meal5 g/kg
(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. 337/79Individually or in combination
E 512Stannous chlorideCanned and bottled white asparagus25 mg/kg as tin
E 520Aluminium sulphate
E 521Aluminium sodium sulphate
E 522Aluminium potassium sulphate
E 523Aluminium ammonium sulphateEgg white30 mg/kg
Candied, crystallised and glacé fruit and vegetables200 mg/kg Individually or in combination, expressed as aluminium
E 541Sodium aluminium phosphate, acidicFine bakery wares (scones and sponge wares only)1 g/kg expressed as aluminium
E 535Sodium ferrocyanide
E 536Potassium ferrocyanide
E 538Calcium ferrocyanideSalt and its substitutes20 mg/kg Individually or in combination. expressed as anhydrous potassium ferrocyanide
E 551Silicon dioxide
E 552Calcium silicate
E 553a

(i)Magnesium silicate

(ii)Magnesium trisilicate(24)

E 553bTalc(24)
E 554Sodium aluminium silicate
E 555Potassium aluminium silicate
E 556Calcium aluminium silicate
E 559Aluminium silicate (Kaolin)Dried powdered foods (including sugars)10 g/kg
Salt and its substitutes10 g/kg
Dietary food supplementsquantum satis
Foods in tablet and coated tablet formquantum satis
Sliced hard cheese and sliced processed cheese10 g/kg Individually or combination

Chewing gum

Rice

Sausages (surface treatment only)

Moulded jelly sweets (surface treatment only)

quantum satis(25)
E 579Ferrous gluconate
E 585Ferrous lactateOlives darkened by oxidation150 mg/kg as iron
E 620Glutamic acid
E 621Monosodium glutamate
E 622Monopotassium glutamate
E 623Calcium diglutamate
E 624Monoammonium glutamate
E 625Magnesium diglutamateFoods in general (except those referred to in Schedules 6, 7 and 8)10 g/kg Individually or in combination
Condiments and seasoningsquantum satis
E 626Guanylic acid
E 627Disodium guanylate
E 628Dipotassium guanylate
E 629Calcium guanylate
E 630Inosinic acid
E 631Disodium inosinate
E 632Dipotassium inosinate
E 633Calcium inosinate
E 634Calcium 5'-ribonucleotides
E 635Disodium 5'-ribonucleotidesFoods in general (except those referred to in Schedules 6, 7 and 8)500 mg/kg individually or in combination, expressed as guanylic acid
Seasonings and condimentsquantum satis
E 900Dimethyl polysiloxaneJam, jellies and marmalades as defined in Directive 79/693/EEC and similar fruit spreads, including low calorie products10 mg/kg
Soups and broths10 mg/kg
Oil and fats for frying10 mg/kg
Confectionery (excluding chocolate)10 mg/kg
Non-alcoholic flavoured drinks10 mg/l
Pineapple juice10 mg/l
Canned and bottled fruit and vegetables10 mg/kg
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. 337/79100 mg/kg
Sød . . . saft10 mg/l
Batters10 mg/kg
E 901Beeswax, white and yellow
E 902Candelilla wax
E 903Carnauba wax
E 904ShellacAs glacing agents only for:
  • Confectionery (including chocolate)

  • Small products of fine bakery wares coated with chocolate

  • Snacks

  • Nuts

  • Coffee beans

quantum satis
Dietary food supplementsquantum satis
Fresh citrus fruits, melons, apples and pears (surface treatment only)quantum satis
E 912Montan acid esters
E 914Oxidised polyethylene waxFresh citrus fruits, (surface treatment only)quantum satis
E 927bCarbamideChewing gum without added sugars30 g/kg
E 950Acesulfame-K
E 951Aspartame
E 957ThaumatinChewing gum with added sugars800 mg/kg(26) 2500 mg/kg(26) 10 mg/kg(26) (as flavour enhancer only)
E 959Neohesperidine DCChewing gum with added sugars150 mg/kg(26)
Margarine
Minarine
Meat products
Fruit jellies
Vegetable proteins5 mg/kg (as flavour enhancer only)
E 999 extractQuillaia extractWater-based flavoured non-alcoholic drinks200 mg/l calculated as anhydrous
E 1201Polyvinylpyrrolidone
E 1202PolyvinylpolypyrrolidoneDietary food supplementsquantum satis in tablet and coated tablet form
E 1505Triethyl citrateDried egg whitequantum 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 4Permitted Carriers and Carrier Solvents

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

Regulations 2(1) and 11(5)

SCHEDULE 5Purity 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

DescriptionFine white microcrystalline or amorphous powder
ContentNot less than 97 per centum of CaCO3 on a volatile matter-free basis
Volatile matterNot more than 1 per centum (determined by drying at 105°C to constant weight)
Matter insoluble in hydrochloric acidShall 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
ArsenicNot more than 5 mg per kg.
LeadNot more than 20 mg per kg.
Other inorganic impuritiesNot 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.

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

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

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.

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 bisulhite

Potassium acid sulphite

The appropriate specific purity criteria contained in Council Directive 65/66/EEC as amended by Council Directive 86/604/EEC(28).

E 230.    Biphenyl, diphenyl

E 231.    Orthophenyl phenol

Synonym

2-Hydroxybiphenyl

E 232.    Sodium orthophenyl phenol

Synonyms

Sodium biphenyl-2-yl-oxide

Sodium orthophenylphenate

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.

E 239.    Hexamethylene tetramine

SynonymHexamine

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, Na2CO3).

In the case of:—

E 262(ii).    Sodium diacetate

SynonymSodium 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.

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

DescriptionWhite or nearly white crystalline powder or granules
Content Melting rangeNot less than 99 per centum of C4H6O5. 99°C to 101°C.
Specific rotation [α] 20°C DNot less than –2.4° and not more than –2.2° using a solution containing 8.5g L-malic and in 100 ml water.

Malic acid

Fumaric acid

Residue on ignition

Water insoluble matter

Shall comply with the limits given in the }monograph for malic acid in the Food 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.

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 78/664/EEC(29).

E 322.    Lecithins

  • The specific purity criteria for lecithins contained in Council Directive 78/664/EEC as amended by Article 1.2 of Council Directive 82/712/EEC(30).

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

SynonymSodium dihydrogen citrate

E 331(ii).    Disodium citrate

E 331(iii).    Trisodium citrate

E 332(i).    Monopotassium citrate

SynonymPotassium 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

E336(ii).    Dipotassium L-(+)-tartrate

E 337.    Sodium potassium L-(+)-tartrate

SynonymPotassium sodium tartrate

E 338.    Phosphoric acid

SynonymOrthophosphoric acid

E 339(i).    Monosodium phosphate

SynonymMonosodium orthophosphate

E 339(ii).    Disodium phosphate

SynonymDisodium orthophosphate Disodium hydrogen orthophosphate

E 339(iii).    Trisodium phosphate

SynonymTrisodium orthophosphate

E 340(i).    Monopotassium phosphate

SynonymsMonodipotassium orthophosphate Potassium dihydrogen orthophosphate

E 340(ii).    Dipotassium phosphate

SynonymsDipotassium orthophosphate Dipotassium hydrogen orthophosphate

E 340(iii).    Tripotassium phosphate

SynonymTripotassium orthophosphate

E 341(i).    Monocalcium phosphate

SynonymsMonocalcium orthophosphate Calcium tetrahydrogen diorthophosphate

E 341(ii).    Dicalcium phosphate

SynonymsDicalcium orthophosphate Calcium hydrogen orthophosphate

E 340(iii).    Tricalcium phosphate

SynonymsTricalcium orthophosphate Tricalcium diorthophosphate
  • the appropriate specific purity criteria contained in Council Directive 78/664/EEC.

E 350(i).    Sodium malate

DescriptionColourless or almost colourless aqueous solution. Sodium malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 59.5 per centum of C4H4O5Na2.
Maleic acidNot more than 0.05 per centum calculated on the C4H4O5Na2 content.

E 350(ii).    Sodium hydrogen malate

DescriptionWhite odourless powder. Sodium hydrogen malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 99 per centum of C4H5O5Na on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.

E 351.    Potassium malate

DescriptionColourless or almost colourless aqueous solution. Potassium malate may be derived from either DL-malic acid or L-malic acid.
ContentNot less than 59.5 per centum of C4H4O5K2
Maleic acidNot more than 0.05 per centum calculated on the C4H4O5K2 content.

E 352(i).    Calcium malate

DescriptionWhite odourless powder. Calcium malate may be derived from either DL-malic acid or L-malic acid
ContentNot less than 97.5 per centum of C4H4O5Ca on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.
FluorideNot more than 30 mg per kg on a volatile matter-free basis

E 352(ii).    Calcium hydrogen malate

DescriptionWhite odourless powder. Calcium hydrogen malate may be derived from either DL-malic acid or L-malic acid
ContentNot less than 97.5 per centum of (C4H5O5)2Ca on a volatile matter-free basis.
Volatile matterNot more than 2 per centum (determined by drying at 110°C for 3 hours)
Maleic acidNot more than 0.05 per centum.
FluorideNot more than 30 mg per kg on a volatile matter-free basis

E 353.    Metatartaric acid

DescriptionWhite 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 1 per centum E 1 cmNot more than 1.5 × 10−2at 430 nm. (determined using a filtered aqueous solution).
IdentificationPlace 5 to 10 mg of sample in a test tube. Add 2 ml sulphuric acid (about 94 per centum H2SO4) plus two drops of resorcinol reagent (2 g. resorcinol dissolved in 100 ml water plus 0.5 ml sulphuric acid) and heat to 150°C. An intense violet colour is produced.
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 metatartaric acid. Titrate with N aqueous sodium hydroxide solution to a blue-green colour (T1ml.). Add a further 20 ml of N aqueous sodium hydroxide solution and leave for 2 hours at room temperature.

Titrate with N aqueous sulphuric acid solution (T2ml).

Calculations:

Specific rotation [α] 20°C DNot 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 acidNot 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

SynonymAmmonium 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

SynonymSodium calciumedate
The criteria in the monograph for sodium calciumedetate contained in the British Pharmacopoeia 1973 at page 425.

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

SynonymPropylene glycol alginate

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(31).

E 410.    Locust bean gum

SynonymCarob gum

E 412.    Guar gum

E 413.    Tragacanth

E 414.    Acacia

SynonymGum arabic

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

SynonymSterculia gum
The criteria in the monograph for karaya gum contained in the Food Chemicals Codex 1981 at page 157.

E 420(i).    Sorbitol

E 420(ii).    Sorbitol syrup

E 421.    Mannitol

  • the appropriate specific purity criteria contained in Commission Directive 95/31/EC(32).

E 422.    Glycerol

As set out in the Annex to Council Directive 78/663/EEC.

E 432.    Polyoxyethylene (20) sorbitan monolaurate

SynonymPolysorbate 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

SynonymPolysorbate 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

SynonymPolysorbate 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

SynonymPolysorbate 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

SynonymPolysorbate 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.

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

DescriptionAmmonium phosphatides exist as an unctuous semi-solid (at 25°C). They consist essentially of a mixture of the ammonium salts of phosphatidic acids derived from partially hardened rapeseed oil together with unreacted partially hardened rape-seed oil.
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 phosphatidesNot less than 6.0 and not more than 8.0
PhosphorusNot less than 3.0 per centum and not more than 3.4 per centum.
Ammonium nitrogenNot less than 1.2 per centum and not more than 1.5 per centum.
ArsenicNot more than 5 mg per kg.

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

SynonymsDicalcium pyrophosphate Calcium pyrophosphate
The criteria in the monograph for calcium pyrophosphate contained in the Food Chemicals Codex 1972 at page 153.

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 71 per centum of 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 phosphateNot more than 8 per centum calculated on the P2O5 content.
FluorideNot 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

SynonymAlpha-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.

E 461.    Methylcellulose

E 463.    Hydroxypropylcellulose

E 464.    Hydroxypropylmethylcellulose

E 465.    Ethylmethylcellulose

SynonymMethylethylcellulose

E 466.    Carboxymethylcellulose

SynonymSodium carboyxmethylcellulose
The specific purity criteria for carboxymethylcellulose contained in Council Directive 78/663/EEC, as amended by Article 1 of Commission Directive 90/612/EEC.

E 470a.    Sodium, potassium and calcium salts of fatty acids

E 471.    Mono- and diglycerides of fatty acids

E 472(a).    Acetic acid esters of mono- and diglycerides of fatty acids

SynonymAcetylated mono- and diglycerides

E 472(b).    Lactic acid esters of mono- and diglycerides of fatty acids

Synonyms

Lactylated mono- and diglycerides

Lactoglycerides

E 472(c).    Citric acid esters of mono- and diglycerides of fatty acids

SynonymCitroglycerides

E 472(d).    Tartaric acid esters of mono- and diglycerides of fatty acids

E 472(e).    Mono-and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids

SynonymMono- and diacetyl tartaric acid esters of mono-and diglycerides

E 472(f).    Mixed acetic and tartaric acid esters of mono- and 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(33).

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 of castor oil.Polyglycerol esters of polycondensed fatty acids
DescriptionThe polyglycerol esters of polycondensed fatty acids of castor oil exist as a highly viscous liquid (at 25°C). They are essentially a complex mixture of the partial esters and ethers of polyglycerol with linearly interesterified (polycondensed) fatty acids derived from castor oil. The polycondensed castor oil fatty acids are prepared by condensation in the absence of oxygen and have an average of about 5 fatty acid residues per molecule. The polyglycerol moiety is predominantly di-, tri- and tetra-glycerol and contains not more than 10 per centum of polyglycerols equal to or higher than heptaglycerol.
Refractive index, m65D°CNot less than 1.4630 and not more than 1.4665.
Hydroxyl valueNot less than 80 and not more than 100.
Iodine valueNot less than 72 and not more than 103 (Wijs).
Acid valueNot more than 6 mg KOH per g.

E 477.    Propane-1,2-diol esters of fatty acids

SynonymPropylene 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.

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

DescriptionColourless crystals or white granular or crystalline powder. The anhydrous salt is hygroscopic and the decahydrate is efflorescent.
ContentNot 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 5 g of hydrated sodium carbonate, or 2.5 g of anhydrous sodium carbonate, with 50 ml of water and 10 ml of dilute ammonia solution (about 10 per centum NH3). Filter and wash the residue with water, then ignite to constant weight.

SulphateNot more than 0.4 per centum on a volatile matter-free basis.
ChlorideNot more than 0.4 per centum on a volatile matter-free basis
IronNot more than 40 mg per kg on a volatile matter-free basis.

E 500(ii).    Sodium hydrogen carbonate

SynonymSodium 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 sesqicarbonate 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.

ContentNot 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

SynonymPotassium 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

SynonymAmmonium 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. 1, 1969 at page 322.

Magnesium carbonate, light

The criteria in the monograph for light magnesium carbonate contained in the European Pharmacopoeia Vol. 1, 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

DescriptionThe 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 saltsNot 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.
FluorideNot 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

SynonymsPotassium 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

DescriptionSoft white powder.
Solubility1 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.
ContentNot 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 saltsNot 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.
CarbonateWhen 2 g of calcium hydroxide is mixed with 50 ml of water and an excess of dilute hydrochloric acid (approximately 2N) is added, no more than a slight effervescence is produced.
SulphateNot more than 0.35 per centum.
FluorideNot 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 hydroxide contained in the Food Chemicals Codex 1972 at page 138.

E 530.    Magnesium oxide

Magnesium oxide, heavy

DescriptionWhite fine odourless powder.
Solubility
  • Practically insoluble in water.

  • Soluble in dilute acids with, at most, slight effervescence.

Apparent volume20 g of heavy magnesium oxide occupies a volume of about 50 ml.
ContentNot 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 ignitionNot more than 5 per centum (determined by ignition at 900°C to 950°C to constant weight).
Matter soluble in waterNot 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 5 g 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.

SulphateNot more than 0.75 per centum.
ChlorideNot more than 0.07 per centum.
CalciumNot more than 2 per centum.
IronNot more than 0.1 per centum.
ArsenicNot more than 4 mg per kg.
Heavy metalsNot 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

SynonymsSodium hexacyanoferrate (II)
The criteria in the monograph for sodium ferrocyanide contained in the Food Chemicals Codex 1972 at page 741.

E 536.    Potassium ferrocyanide

SynonymPotassium hexacyanoferrate (II)
DescriptionOdourless lemon yellow crystals.
SolubilitySoluble in water and in acetone. Insoluble in ethanol, in ether and in hydrocarbons.
ContentNot less than 98 per centum of K4Fe(CN)6. 3H2O.
Free moistureNot 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).
ChlorideNot more than 0.1 per centum.
SulphateNot 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

SynonymSilica, chemically prepared.
DescriptionSilica aerogel is a whie fluffy powdered or granular microcellular silica. Hydrated silica is a precipitated hydrated silicon dioxide occurring as a fine white amorphous powder or as beads or granules.
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 matterHydrated silica: not more than 7 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot 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

DescriptionWhite 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 matterNot more than 6 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot 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

DescriptionTalc 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 sodum silicate.

  • Sodium aluminosilicate.

  • Sodium silicoaluminate.

DescriptionFine 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 matterNot more than 8 per centum (determined by drying at 105°C for 2 hours)
Loss on ignitionNot 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.

DescriptionFine 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 matterNot more than 10 per centum (determined by drying at 105°C for 2 hours).
Loss on ignitionNot 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 Pharmaccopoeia 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

SynonymD-Glucono-l,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

DescriptionWhite free-flowing powder.
SolubilityFreely soluble in water. Practically insoluble in ethanol and in ether.
ContentNot less than 97 per centum of C6H11O7K on a volatile matter-free basis.
Volatile matterNot 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.

FormulaC5H8NNaO4.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.

FormulaC10H12N5Na2O8P.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.

FormulaC10H11N4Na2O8P.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.

ContentNot 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.
MoistureNot 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 acidsPlace 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 nucleotidesThe 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

SynonymDimethyl silicone.
AppearanceClear colourless odourless liquid free from extraneous matter.
Solubility
  • Insoluble in water.

  • Soluble in most aliphatic and aromatic hydrocarbon solvents.

Volatile matterNot more than 2 per centum (determined by drying at 200°C for 4 hours).
IdentificationShall comply with the identification tests in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
AcidityShall comply with the requirement for acidity in the monograph for dimethicone in the British Pharmaceutical Codex 1973 at page 168.
Total siliconNot less than 37.3 and not more than 38.5 per centum.
Refractive index n 25°C DNot 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°C 4°CNot 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.

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

Xylitol

  • E 967.  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

DescriptionPolydextrose 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.
ContentNot less than 90% of polymer on an ash-free and water-free basis.
Free glucoseNot more than 4% of an ash-free and water-free basis.
Free 1,6 anhydro-D-glucoseNot more than 4% on an ash-free and water-free basis.
Free sorbitalNot more than 2% on an ash-free and water-free basis.
WaterNot 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 ashNot more than 0.3% (not more than 3.0% for the neutralised product).
ArsenicNot more than 1 mg/kg.
LeadNot 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 6Foods in which Miscellaneous Additives listed in Schedule 1 are generally prohibited

  • Unprocessed foods

  • Honey as defined in Directive 74/409/EEC(34)

  • 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(35) 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 7Foods in which a limited number of Miscellaneous Additives listed in Schedule 1 may be used

Column 1Column 2Column 3
FoodAdditiveMaximum level
Cocoa and chocolate products as defined in Directive 73/241/EEC(36)E 330Citric acid0.5%
E 322Lecithinsquantium satis
E 334Tartaric acid0.5%
E 422Glycerolquantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
E 170Calcium carbonates7% on dry matter without fat expressed as potassium carbonates
E 500Sodium carbonates7% on dry matter without fat expressed as potassium carbonates
E 501Potassium carbonates7% on dry matter without fat expressed as potassium carbonates
E 503Ammonium carbonates7% on dry matter without fat expressed as potassium carbonates
E 504Magnesium carbonates7% on dry matter without fat expressed as potassium carbonates
E 524Sodium hydroxide7% on dry matter without fat expressed as potassium carbonates
E 525Potassium hydroxide7% on dry matter without fat expressed as potassium carbonates
E 526Calcium hydroxide7% on dry matter without fat expressed as potassium carbonates
E 527Ammonium hydroxide7% on dry matter without fat expressed as potassium carbonates
E 528Magnesium hydroxide7% on dry matter without fat expressed as potassium carbonates
E 530Magnesium oxide7% on dry matter without fat expressed as potassium carbonates
E 414Acacia gumas glazing agents only quantum satis
E 440Pectinsas glazing agents only quantum satis
Fruit juices and nectars as defined in Directive 93/77/EEC(37)E 300Ascorbic acidquantum satis
Pineapple juice as defined in Directive 93/77/EECE 296Malic acid3 g/l
Nectars as defined in Directive 93/77/EECE 330Citric acid5 g/l
E 270Lactic acid5 g/l
Grape juice as defined in Directive 93/77/EECE 170Calcium carbonatesquantum satis
E 336Potassium tartratesquantum satis
Fruit juices as defined in Directive 93/77/EECE 330Citric acid3 g/l
Extra jam and extra jelly, as defined in Directive 79/693/EECE 270Lactic acidquantum satis
E 296Malic acidquantum satis
E 300Ascorbic acidquantum satis
E 327Calcium lactatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 333Calcium citratesquantum satis
E 334Tartaric acidquantum satis
E 335Sodium tartratesquantum satis
E 350Sodium malatesquantum satis
E 440Pectinsquantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
Jams, jellies and marmalades as defined in Directive 79/693/EEC and other similar fruit spreads including low-calorie productsE 270Lactic acidquantum satis
E 296Malic acidquantum satis
E 300Ascorbic acidquantum satis
E 327Calcium lactatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 333Calcium citratesquantum satis
E 334Tartaric acidquantum satis
E 335Sodium tartratesquantum satis
E 350Sodium malatesquantum satis
E 400Alginic acid10 g/kg (individually or in combination)
E 401Sodium alginate10 g/kg (individually or in combination)
E 402Potassium alginate10 g/kg (individually or in combination)
E 403Ammonium alginate10 g/kg (individually or in combination)
E 404Calcium alginate10 g/kg (individually or in combination)
E 406Agar10 g/kg (individually or in combination)
E 407Carrageenan10 g/kg (individually or in combination)
E 410Locust bean gum10 g/kg (individually or in combination)
E 412Guar gum10 g/kg (individually or in combination)
E 415Xanthan gum10 g/kg (individually or in combination)
E 418Gellan gum10 g/kg (individually or in combination)
E 440Pectinsquantum satis
E 509Calcium chloridequantum satis
E 524Sodium hydroxidequantum satis
Partially dehydrated and dehydrated milk as defined in Directive 76/118/EEC(38)E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 304Fatty acid esters of ascorbic acidquantum satis
E 322Lecithinsquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 407Carrageenanquantum satis
E 500(ii) Sodium bicarbonatequantum satis
E 501(ii) Potassium bicarbonatequantum satis
E 509Calcium chloridequantum satis
Sterilised, pasteurised and UHT cream, low-calorie cream and pasteurised low-fat creamE 270Lactic acidquantum satis
E 322Lecithinsquantum satis
E 325Sodium lactatequantum satis
E 326Potassium lactatequantum satis
E 327Calcium lactatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
E 400Alginic acidquantum satis
E 401Sodium alginatequantum satis
E 402Potassium alginatequantum satis
E 403Ammonium alginatequantum satis
E 404Calcium alginatequantum satis
E 406Agarquantum satis
E 407Carrageenanquantum satis
E 410Locust bean gumquantum satis
E 415Xanthan gumquantum satis
E 440Pectinsquantum satis
E 460Cellulosesquantum satis
E 461Methyl cellulosequantum satis
E 463Hydroxypropyl cellulosequantum satis
E 464Hydroxypropyl methyl cellulosequantum satis
E 465Ethyl methyl cellulosequantum satis
E 466Carboxy methyl cellulose Sodium carboxy methyl cellulosequantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
E 508Potassium chloridequantum satis
E 509Calcium chloridequantum satis
E 1404Oxidised starchquantum satis
E 1410Monostarch phosphatequantum satis
E 1412Distarch phosphatequantum satis
E 1413Phosphated distarch phosphatequantum satis
E 1414Acetylated distarch phosphatequantum satis
E 1420Acetylated starchquantum satis
E 1422Acetylated distarch adipatequantum satis
E 1440Hydroxy propyl starchquantum satis
E 1442Hydroxy propyl distarch phosphatequantum satis
E 1450Starch sodium octenyl succinatequantum satis
Frozen and deep-frozen unprocessed fruit and vegetables Fruit compote Unprocessed fish, crustaceans and molluscs, including such products frozen and deep-frozenE 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 302Calcium ascorbatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
Quick-cook riceE 471Mono- and diglycerides of fatty acidsquantum satis
E 472aAcetic acid esters of mono- and diglycerides of fatty acidsquantum satis
Non emulsified oils and fats of animal or vegetable origin (except virgin oils and olive oils)E 304Fatty acid esters of ascorbic acidquantum satis
E 306Tocopherol-rich extractquantum satis
E 307Alpha-tocopherolquantum satis
E 308Gamma-tocopherolquantum satis
E 309Delta-tocopherolquantum satis
E 322Lecithins30 g/l
E 471Mono- and diglycerides of fatty acids10 g/l
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
Refined olive oil, including olive pomace oilE 307Alpha-tocopherol200 mg/l
Ripened cheeseE 170Calcium carbonatesquantum satis
E 504Magnesium carbonatesquantum satis
E 509Calcium chloridequantum satis
E 575Glucono-delta-lactonequantum satis
Mozzarella and whey cheeseE 270Lactic acidquantum satis
E 330Citric acidquantum satis
E 575Glucono-delta-lactonequantum satis
Canned and bottled fruit and vegetablesE 260Acetic acidquantum satis
E 261Potassium acetatequantum satis
E 262Sodium acetatesquantum satis
E 263Calcium acetatequantum satis
E 270Lactic acidquantum satis
E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 302Calcium ascorbatequantum satis
E 325Sodium lactatequantum satis
E 326Potassium lactatequantum satis
E 327Calcium lactatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
E 334Tartaric acidquantum satis
E 335Sodium tartratesquantum satis
E 336Potassium tartratesquantum satis
E 337Sodium potassium tartratequantum satis
E 509Calcium chloridequantum satis
E 575Glucono-delta-lactonequantum satis
GehaktE 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
Pre-packed preparations of fresh minced meatE 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 302Calcium ascorbatequantum satis
E 330Citric acidquantum satis
E 331Sodium citratesquantum satis
E 332Potassium citratesquantum satis
E 333Calcium citratesquantum satis
Bread prepared solely with the following ingredients: wheat-flour, water, yeast or leaven, saltE 260Acetic acidquantum satis
E 261Potassium acetatequantum satis
E 262Sodium acetatesquantum satis
E 263Calcium acetatequantum satis
E 270Lactic acidquantum satis
E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 302Calcium ascorbatequantum satis
E 304Fatty and acid esters of ascorbic acidquantum satis
E 322Lecithinsquantum satis
E 325Sodium lactatequantum satis
E 326Potassium lactatequantum satis
E 327Calcium lactatequantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
E 472aAcetic acid esters of mono- and diglycerides of fatty acidsquantum satis
E 472dTartaric acid esters of mono- and diglycerides of fatty acidsquantum satis
E 472eMono- and diacetyl tartaric acid esters of mono- and diglycerides of fatty acidsquantum satis
E 472fMixed acetic and tartaric acid esters of mono- and diglycerides of fatty acidsquantum satis
Pain courant françaisE 260Acetic acidquantum satis
E 261Potassium acetatequantum satis
E 262Sodium acetatesquantum satis
E 263Calcium acetatequantum satis
E 270Lactic acidquantum satis
E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 302Calcium ascorbatequantum satis
E 304Fatty acid esters of ascorbic acidquantum satis
E 322Lecithinsquantum satis
E 325Sodium lactatequantum satis
E 326Potassium lactatequantum satis
E 327Calcium lactatequantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
Fresh pastaE 270Lactic acidquantum satis
E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 322Lecithinsquantum satis
E 330Citric acidquantum satis
E 334Tartaric acidquantum satis
E 471Mono- and diglycerides of fatty acidsquantum satis
E 575Glucono-delta-lactonequantum satis
Wines and sparkling wines and partially fermented grape mustAdditives 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 undegone oenological processes not provided for in Regulation (EEC) No. 337/79pro memoria
BeerE 270Lactic acidquantum satis
E 300Ascorbic acidquantum satis
E 301Sodium ascorbatequantum satis
E 330Citric acidquantum satis
E 414Acacia gumquantum satis
Foie gras, foie gras entier, blocs de foie grasE 300Ascorbic acidquantum satis
E 301Sodium ascorbatquantum satis

Regulation 3(7) and (8)

SCHEDULE 8Miscellaneous 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 manufacturer’s instructions.

Part IMiscellaneous 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.NameMaximum level
E 270Lactic acid (L(+)-form only)quantum satis
E 330Citric acidquantum satis
E 338Phosphoric acidIn conformity with the limits set in Annex 1 to Directive 91/321/EEC
E 306Tocopherol-rich extract10 mg/l individually or in combination
E 307Alpha-tocopherol10 mg/l individually or in combination
E 308Gamma-tocopherol10 mg/l individually or in combination
E 309Delta-tocophorol10 mg/l individually or in combination
E 322Lecithins1 g/l
E 471Mono- and diglycerides of fatty acids4 g/l

Part IIMiscellaneous additives permitted in follow-on formulae for infants in good health

Notes

(a)For the manufacture of acidified milks, non-pathogenic L(+)-lactic acid producting 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 subsances is lowered with that relative part as is present of the other substances together in that food.

EC No.NameMaximum level
E 270Lactic acid (L(+)-form only)quantum satis
E 330Citric acidquantum satis
E 306Tocopherol-rich extract10 mg/l individually or in combination
E 307Alpha-tocopherol10 mg/l individually or in combination
E 308Gamma-tocopherol10 mg/l individually or in combination
E 309Delta-tocopherol10 mg/l individually or in combination
E 338Phosphoric acidIn conformity with the limits set in Annex II to Directive 91/321/EEC
E 440Pectins5 g/l in acidified follow-on formulae only
E 322Lecithins1 g/l
E 471Mono- and diglycerides of fatty acids4 g/l
E 407Carrageenan0.3 g/l
E 410Locust bean gum1 g/l
E 412Guar gum1 g/l

Part IIIMiscellaneous additives permitted in weaning foods for infants and young children in good health

EC No.NameFoodMaximum level
E 170Calcium carbonatesWeaning foodsquantum satis (only for pH adjustment)
E 260Acetic acidWeaning foodsquantum satis (only for pH adjustment)
E 261Potassium acetateWeaning foodsquantum satis (only for pH adjustment)
E 262Sodium acetatesWeaning foodsquantum satis (only for pH adjustment)
E 263Calcium acetateWeaning foodsquantum satis (only for pH adjustment)
E 270Lactic acid(39)Weaning foodsquantum satis (only for pH adjustment)
E 296Malic acid(39)Weaning foodsquantum satis (only for pH adjustment)
E 325Sodium lactate(39)Weaning foodsquantum satis (only for pH adjustment)
E 326Potassium lactate(39)Weaning foodsquantum satis (only for pH adjustment)
E 327Calcium lactate(39)Weaning foodsquantum satis (only for pH adjustment)
E 330Citric acidWeaning foodsquantum satis (only for pH adjustment)
E 331Sodium citratesWeaning foodsquantum satis (only for pH adjustment)
E 332Potassium citratesWeaning foodsquantum satis (only for pH adjustment)
E 333Calcium citratesWeaning foodsquantum satis (only for pH adjustment)
E 507Hydrochloric acidWeaning foodsquantum satis (only for pH adjustment)
E 524Sodium hydroxideWeaning foodsquantum satis (only for pH adjustment)
E 525Potassium hydroxideWeaning foodsquantum satis (only for pH adjustment)
E 526Calcium hydroxideWeaning foodsquantum satis (only for pH adjustment)
E 500Sodium carbonatesWeaning foodsquantum satis (only as raising agents)
E 501Potassium carbonatesWeaning foodsquantum satis (only as raising agents)
E 503Ammonium carbonatesWeaning foodsquantum satis (only as raising agents)
E 300L-ascorbic acid

Fruit- and vegetable-based drinks, juices and baby drinks

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 301Sodium L-ascorbate

Fruit- and vegetable-based drinks, juices and baby drinks

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 302Calcium L-ascorbate

Fruit- and vegetable-based drinks, juices and baby drinks

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 304L-ascorbyl palmitateFat-containing cereals, biscuits, rusks and baby foods0.1 g/Kg individually or in combination
E 306Tocopherol-rich extractFat-containing cereals, biscuits, rusks and baby foods0.1 g/Kg individually or in combination
E 307Alpha-tocopherolFat-containing cereals, biscuits, rusks and baby foods0.1 g/Kg individually or in combination
E 308Gamma-tocopherolFat-containing cereals, biscuits, rusks and baby foods0.1 g/Kg individually or in combination
E 309Delta-tocopherolFat-containing cereals, biscuits, rusks and baby foods0.1 g/Kg individually or in combination
E 338Phosphoric acidWeaning foods1 g/kg as P2O5 (only for pH adjustment)
E 339Sodium phosphatesCereals1 g/kg individually or in combination, expressed as P2O5
E 340Potassium phosphatesCereals1 g/kg individually or in combination, expressed as P2O5
E 341Calcium phosphatesCereals1 g/kg individually or in combination, expressed as P2O5
E 322LecithinsBiscuits and rusks Cereal-based foods Baby foods10 g/kg
E 471Mono- and diglycerides of fatty acidsBiscuits and rusks Cereal-based foods Baby foods5 g/kg individually or in combination
E 472aAcetic acid esters of mono- and diglycerides of fatty acidsBiscuits and rusks Cereal-based foods Baby foods5 g/kg individually or in combination
E 472bLactic acid esters of mono- and diglycerides of fatty acidsBiscuits and rusks Cereal-based foods Baby foods5 g/kg individually or in combination
E 472cCitric acid esters of mono- and diglycerides of fatty acidsBiscuits and rusks Cereal-based foods Baby foods5 g/kg individually or in combination
E 400Alginic acid

Desserts

Puddings

0.5 g/kg individually or in combination
E 401Sodium alginate

Desserts

Puddings

0.5 g/kg individually or in combination
E 402Potassium alginate

Desserts

Puddings

0.5 g/kg individually or in combination
E 404Calcium alginate

Desserts

Puddings

0.5 g/kg individually or in combination
E 410Locust bean gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 412Guar gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 414Acacia gum (gum arabic)

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 415Xanthan gum

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 440Pectins

Weaning foods

Gluten-free cereal-based foods

10 g/kg individually or in combination

20 g/kg individually or in combination

E 551Silicon dioxideDry cereals2 g/kg
E 334Tartaric acid(40)Biscuits and rusks5 g/kg as a residue
E 335Sodium tartrate(40)Biscuits and rusks5 g/kg as a residue
E 336Potassium tartrate(40)Biscuits and rusks5 g/kg as a residue
E 354Calcium tartrate(40)Biscuits and rusks5 g/kg as a residue
E 450aDisodium diphosphateBiscuits and rusks5 g/kg as a residue
E 575Glucono-delta-lactoneBiscuits and rusks5 g/kg as a residue
E 1404Oxidised starchWeaning foods50 g/kg
E 1410Monostarch phosphateWeaning foods50 g/kg
E 1412Distarch phosphateWeaning foods50 g/kg
E 1413Phosphated distarch phosphateWeaning foods50 g/kg
E 1414Acetylated distarch phosphateWeaning foods50 g/kg
E 1420Acetylated starchWeaning foods50 g/kg
E 1422Acetylated distarch adipateWeaning foods50 g/kg
E 1450Starch sodium octenyl succinateWeaning foods50 g/kg

Part IVMiscellaneous 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 9Revocations

Column 1Column 2Column 3
Regulations and order revokedReferencesExtent of revocation
The Meat (Treatment) Regulations (Northern Ireland) 1964S.R. & O. (N.I.) 1964 No. 6The whole Regulations
The Mineral Hydrocarbons in Food Regulations (Northern Ireland) 1966S.R. & O. (N.I.) 1966 No. 200In regulation 2(1), the definition of “dried fruit”
The Solvents in Food Regulations (Northern Ireland) 1967S.R. & O. (N.I.) 1967 No. 282The whole Regulations
The Specified Sugar Products Regulations (Northern Ireland) 1976S.R. 1976 No. 165In 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). Schedule 3.
The Cocoa and Chocolate Products Regulations (Northern Ireland) 1976S.R. 1976 No. 183In regulation (2)1, the definitions of “permitted acid”, “permitted base” and “permitted emulsifier”. In Schedule 2, Part I.
The Fruit Juices and Fruit Nectars Regulations (Northern Ireland) 1977S.R. 1977 No. 182In regulation 2(1), the definitions of “anti-foaming agent”, “permitted acid”, “permitted anti-foaming agent” and “permitted preservative”. Regulation 2(2). Regulation 6(a). In Part III of Schedule 2, in the definition of “sucrose solution”, paragraph (e). Schedule 3
The Condensed Milk and Dried Milk Regulations (Northern Ireland) 1977S.R. 1977 No. 196In regulation 2(1), the definitions of “permitted anti-caking agent”, “permitted antioxidant” and “permitted emulsifier” . Regulation 2(4). Regulation 5A(e). Schedule 2.
The Antioxidants in Food Regulations (Northern Ireland) 1978S.R. 1978 No. 112The whole Regulations.
The Coffee and Coffee Products Regulations (Northern Ireland) 1979S.R. 1979 No. 51In regulation 2(1), the definitions of “permitted anti-caking agent” and “permitted preservative”. Regulation 5A(d)
The Antioxidants in Food (Amendment) Regulations (Northern Ireland) 1981S.R. 1981 No. 191The whole Regulations.
The Solvents in Food (Amendment) Regulations (Northern Ireland) 1981S.R. 1981 No. 192The whole Regulations.
The Miscellaneous Additives in Food Regulations (Northern Ireland) 1981S.R. 1981 No. 193The whole Regulations.
The Jam and Similar Products Regulations (Northern Ireland) 1982S.R. 1982 No. 105Regulation 11(5). Regulation 12(2). In regulation 12(2C), the words “Subject to paragraph (2D),”. 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 (Northern Ireland) 1982S.R. 1982 No. 258The whole Regulations.
The Cocoa and Chocolate Products (Amendment) Regulations (Northern Ireland) 1982S.R. 1982 No. 349Regulation 2(5). The Schedule.
The Fruit Juices and Fruit Nectars (Amendment) Regulations (Northern Ireland) 1983S.R. 1983 No. 48Regulation 8.
The Meat Products and Spreadable Fish Products Regulations (Northern Ireland) 1984S.R. 1984 No. 408In 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 and Mode of Trial) Regulations (Northern Ireland) 1987S.R. 1987 No. 38In Schedule 1, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978 and the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981.
The Condensed Milk and Dried Milk (Amendment) Regulations (Northern Ireland) 1987S.R. 1987 No. 65Regulation 2(b).
The Preservatives in Food Regulations (Northern Ireland) 1989S.R. 1989 No 152The whole Regulations.
The Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989S.R. 1989 No. 308The whole Regulations.
The Preservatives in Food (Amendment) Regulations (Northern Ireland) 1989S.R. 1989 No. 460The whole Regulations.
The Jam and Similar Products (Amendment) Regulations (Northern Ireland) 1990S.R. 1990 No. 388Regulation 2(6)(a) and (c), (7), (9)(c) and (d).
The Food Safety (Northern Ireland) Order 1991 (Consequential Modifications) Order (Northern Ireland) 1991S.R. 1991 No. 203Article 12. In Part I of Schedule 1, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 2, the references to the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 3, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978 and the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981. In Schedule 4, the reference to the Meat (Treatment) Regulations (Northern Ireland) 1964. In Schedule 5, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 6, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989. In Schedule 10, the references to the Meat (Treatment) Regulations (Northern Ireland) 1964, the Solvents in Food Regulations (Northern Ireland) 1967, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989.
The Fruit Juices and Fruit Nectars (Amendment) Regulations (Northern Ireland) 1991S.R. 1991 No. 251Regulation 2(5)(a) and (7).
The Food Safety (Exports) Regulations (Northern Ireland) 1991S.R. 1991 No. 344In the Schedule, the references to the Solvents in Food Regulations (Northern Ireland) 1967, the Antioxidants in Food Regulations (Northern Ireland) 1978, the Miscellaneous Additives in Food Regulations (Northern Ireland) 1981, the Preservatives in Food Regulations (Northern Ireland) 1989 and the Emulsifiers and Stabilisers in Food Regulations (Northern Ireland) 1989
The Antioxidants in Food (Amendment) Regulations (Northern Ireland) 1991S.R. 1991 No. 495The whole Regulations.
The Emulsifiers and Stabilisers in Food (Amendment) Regulations (Northern Ireland) 1992S.R. 1992 No. 67The whole Regulations.
The Food Additives Labelling Regulations (Northern Ireland) 1992S.R. 1992 No. 417Regulation 7(2), (3) and (5).
The Emulsifiers and Stabilisers in Food (Amendment) Regulations (Northern Ireland) 1993S.R. 1993 No. 236The whole Regulations.
(1)

O.J. No. L149, 14.6.91, pp. 1-9

(2)

O.J. No. L84, 27.3.87, p. 1

(3)

In edible parts

(4)

O.J. No. L205, 13.8.79, p. 5

(5)

O.J. No. L356, 27.12.73, p. 71

(6)

O.J. No. L373, 31.12.88, p. 59

(7)

O.J. No. L231, 13.8.92, p. 1

(8)

O.J. No. L176, 3.7.84, p. 6

(9)

O.J. 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 Back [12]

(13)

Residual amount at point of sale to the final consumer, expressed as NaNO2 Back [13]

(14)

Expressed as NaNO3 Back [14]

(15)

Residual amount nitrite formed from nitrate included, expressed as NaNO2 Back [15]

(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)

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

(28)

O.J. No. L352, 13.12.86, p. 45

(29)

O.J. No. L223, 14.8.78, p. 30

(30)

O.J. No. L297, 23.10.82, p. 31

(31)

O.J. No. L326, 24.11.90, p. 58

(32)

O.J. No. L178, 28.7.95, p. 1

(33)

O.J. No. L55, 29.2.92, p. 96

(34)

O.J. No. L221, 12.8.74, p. 10

(35)

O.J. No. L229, 30.8.80, p. 1

(36)

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

(37)

O.J. No. L224, 30.9.93, p. 23

(38)

O.J. No. L24, 30.1.76, p. 49

(39)

L(+)-form only

(40)

L(+)-form only

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