Search Legislation

Miscellaneous Food Additives Regulations (Northern Ireland) 1996

 Help about what version

What Version

  • Latest available (Revised)
  • Original (As made)

More Resources

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

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(1).

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(2).

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(3).

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(4).

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(5).

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(6).

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.
(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

Back to top

Options/Help

Print Options

You have chosen to open The Whole Rule

The Whole Rule you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open The Whole Rule as a PDF

The Whole Rule you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open This Schedule only

This Schedule only you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open This Schedule only as a PDF

This Schedule only you have selected contains over 200 provisions and might take some time to download.

Would you like to continue?

You have chosen to open the Whole Rule

The Whole Rule you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources