02012R0231 — EN — 01.09.2022 — 026.001

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►B COMMISSION REGULATION (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (Text with EEA relevance) (OJ L 083 22.3.2012, p. 1)

Amended by:









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COMMISSION REGULATION (EU) No 231/2012

of 9 March 2012

laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council

(Text with EEA relevance)







Article 1

Specifications for food additives

Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 are laid down in the Annex to this Regulation.

Article 2

Repeals

Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012.

Article 3

Transitional measures

Foodstuffs containing food additives that have been lawfully placed on the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted.

Article 4

Entry into force

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

It shall apply from 1 December 2012.

However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.

This Regulation shall be binding in its entirety and directly applicable in the Member States.









ANNEX

▼M37

Ethylene oxide may not be used for sterilising purposes in food additives.

No residue above 0,1 mg/kg, irrespective of its origin, of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide ( 1 )) shall be present in food additives listed in Annexes II and III to Regulation (EC) No 1333/2008, including mixtures of food additives.

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Aluminium lakes for use in colours only where explicitly stated.







Definition: Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product. HCl insoluble matter Not more than 0,5 % ΝaΟΗ insoluble matter Νot more than 0,5 %, for Ε 127 erythrosine only Ether extractable matter Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable.

E 100 CURCUMIN







Synonyms CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane Definition Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallization. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present. Curcumin is also used as the aluminium lake; the aluminium content is less than 30 %. Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol. Colour Index No 75300 Einecs 207-280-5 Chemical name I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione Chemical formula I C21H20O6 II C20H18O5 III C19H16O4 Molecular weight I. 368,39 II. 338,39 III. 308,39 Assay Content not less than 90 % total colouring matters 1 607 at ca. 426 nm in ethanol Description Orange-yellow crystalline powder Identification Spectrometry Maximum in ethanol at ca. 426 nm Melting range 179 °C-182 °C Purity Solvent residues Ethylacetate Not more than 50 mg/kg, singly or in combination Acetone n-butanol Methanol Ethanol Hexane Propan-2-ol Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 101 (i) RIBOFLAVIN







Synonyms Lactoflavin; Definition Colour Index No Einecs 201-507-1 Chemical name 7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine Chemical formula C17H20N4O6 Molecular weight 376,37 Assay Content not less than 98 % on the anhydrous basis 328 at ca. 444 nm in aqueous solution Description Yellow to orange-yellow crystalline powder, with slight odour Identification Spectrometry The ratio A375/A267 is between 0,31 and 0,33 in aqueous solution The ratio A444/A267 is between 0,36 and 0,39 Maximum in water at ca. 375 nm Specific rotation [α]D 20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution Purity Loss on drying Not more than 1,5 % (105 °C, 4 hours) Sulphated ash Not more than 0,1 % Primary aromatic amines Not more than 100 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

▼M14

Aluminium lakes of this colour may be used.

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E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE







Synonyms Riboflavin-5′-phosphate sodium Definition These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate. Colour Index No Einecs 204-988-6 Chemical name Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin Chemical formula For the dihydrate form: C17H20N4NaO9P · 2H2O For the anhydrous form: C17H20N4NaO9P Molecular weight 514,36 Assay Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O 250 at ca. 375 nm in aqueous solution Description Yellow to orange crystalline hygroscopic powder, with slight odour Identification Spectrometry The ratio A375/A267 is between 0,30 and 0,34 in aqueous solution The ratio A444/A267 is between 0,35 and 0,40 Maximum in water at ca. 375 nm Specific rotation [α]D 20 between + 38° and + 42° in a 5 molar HCl solution Purity Loss on drying Not more than 8 % (100 °C, 5 hours in vacuum over P2O5) for the dihydrate form Sulphated ash Not more than 25 % Inorganic phosphate Not more than 1,0 % (calculated as PO4 on the anhydrous basis) Subsidiary colouring matters Riboflavin (free): Not more than 6 % Riboflavine diphosphate: Not more than 6 % Primary aromatic amines Not more than 70 mg/kg (calculated as aniline) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

▼M14

Aluminium lakes of this colour may be used.

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E 102 TARTRAZINE







Synonyms CI Food Yellow 4 Definition Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 19140 Einecs 217-699-5 Chemical name Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate Chemical formula C16H9N4Na3O9S2 Molecular weight 534,37 Assay Content not less than 85 % total colouring matters calculated as the sodium salt 530 at ca. 426 nm in aqueous solution Description Light orange powder or granules Appearance of the aqueous solution Yellow Identification Spectrometry Maximum in water at ca. 426 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4-hydrazinobenzene sulfonic acid Total not more than 0,5 % 4-aminobenzene-1-sulfonic acid 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid 4,4′-diazoaminodi(benzene sulfonic acid) Tetrahydroxysuccinic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 104 QUINOLINE YELLOW







Synonyms CI Food Yellow 13 Definition Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione or a mixture containing about two thirds 2-(2-quinolyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 47005 Einecs 305-897-5 Chemical name The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component) Chemical formula C18H9N Na2O8S2 (principal component) Molecular weight 477,38 (principal component) Assay Content not less than 70 % total colouring matters calculated as the sodium salt Quinoline Yellow shall have the following composition: Of the total colouring matters present: — not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates — not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates — not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate 865 (principal component) at ca. 411 nm in aqueous acetic acid solution Description Yellow powder or granules Appearance of the aqueous solution Yellow Identification Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 4,0 % Organic compounds other than colouring matters: 2-methylquinoline Total not more than 0,5 % 2-methylquinoline-sulfonic acid Phthalic acid 2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid 2-(2-quinolyl)indan-1,3-dione Not more than 4 mg/kg Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 110 SUNSET YELLOW FCF







Synonyms CI Food Yellow 3; Orange Yellow S Definition Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried. Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 15985 Einecs 220-491-7 Chemical name Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate Chemical formula C16H10N2Na2O7S2 Molecular weight 452,37 Assay Content not less than 85 % total colouring matters calculated as the sodium salt 555 at ca. 485 nm in aqueous solution at pH 7 Description Orange-red powder or granules Appearance of the aqueous solution Orange Identification Spectrometry Maximum in water at ca. 485 nm at pH 7 Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 5,0 % 1-(Phenylazo)-2-naphthalenol (Sudan I) Not more than 0,5 mg/kg Organic compounds other than colouring matters: 4-aminobenzene-1-sulfonic acid Total not more than 0,5 % 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 4,4′-diazoaminodi(benzene sulfonic acid) 6,6′-oxydi(naphthalene-2-sulfonic acid) Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

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E 120 CARMINIC ACID, CARMINE







Synonyms CI Natural Red 4 Definition Carminic acid is obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa. Carmines are aluminium lakes of carminic acid in which aluminium and carminic acid are thought to be present in the molar ratio 1:2. The colouring principle is carminic acid. Minor amounts of its aminated form 4-aminocarminic acid may also be present. In commercial products the colouring principle carminic acid may be present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess. Commercial products may also contain proteinaceous material derived from the source insect. Colour Index No 75470 Einecs Carminic acid: 215-023-3; carmines: 215-724-4 Chemical name 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid Chemical formula C22H20O13 (carminic acid) Molecular weight 492,39 (carminic acid) Assay Content not less than 90 % carminic acid; not less than 50 % carminic acid in the chelates. Description Red to dark red, friable, solid or powder Identification Spectrometry Carminic acid: Maximum in aqueous ammonia solution at ca. 518 nm Maximum in dilute hydrochloric solution at ca. 494 nm E 1 %/1 cm 139 at peak around 494 nm in dilute hydrochloric acid 4-aminocarminic acid: Maximum in aqueous ammonia solution at 535 nm Maximum in dilute hydrochloric solution at 530 nm E 1 %/1 cm 260 at peak around 535 nm in aqueous ammonia solution, pH 9,5 In commercial products carminic acid may be differentiated from its amine by HPLC Purity Solvent residues Ethanol: Methanol: Not more than 150 mg/kg Not more than 50 mg/kg Total ash Carminic acid: Carmine: Not more than 5 % Not more than 12 % Protein (N × 6,25) Carminic acid: Carmine: Not more than 2,2 % Not more than 25 % 4-aminocarminic acid Not more than 3 % relative to carminic acid Matter insoluble in dilute ammonia Carmine: Not more than 1 % Arsenic Not more than 1 mg/kg Lead Not more than 1,5 mg/kg Mercury Not more than 0,5 mg/kg Cadmium Not more than 0,1 mg/kg Microbiological criteria Salmonella spp. Absent in 10 g

Aluminium lakes of this colour may be used .

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E 122 AZORUBINE, CARMOISINE







Synonyms CI Food Red 3 Definition Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 14720 Einecs 222-657-4 Chemical name Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate Chemical formula C20H12N2Na2O7S2 Molecular weight 502,44 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 510 at ca. 516 nm in aqueous solution Description Red to maroon powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 516 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 4-hydroxynaphthalene-1-sulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 123 AMARANTH







Synonyms CI Food Red 9 Definition Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1-naphthalenesulphonic acid with 3-hydroxy-2,7-naphthalenedisulphonic acid. Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 16185 Einecs 213-022-2 Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 440 at ca. 520 nm in aqueous solution Description Reddish-brown powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 520 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 3,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 124 PONCEAU 4R, COCHINEAL RED A







Synonyms CI Food Red 7; New Coccine Definition Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid (2-naphthol-6,8- disulphonic acid) and converting the coupling product to the trisodium salt. Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 16255 Einecs 220-036-2 Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate Chemical formula C20H11N2Na3O10S3 Molecular weight 604,48 Assay Content not less than 80 % total colouring matters, calculated as the sodium salt. 430 at ca. 505 nm in aqueous solution Description Reddish powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 505 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid Total not more than 0,5 % 7-hydroxynaphthalene-1,3-disulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 127 ERYTHROSINE







Synonyms CI Food Red 14 Definition Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components. Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 45430 Einecs 240-474-8 Chemical name Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate Chemical formula C20H6I4Na2O5 H2O Molecular weight 897,88 Assay Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt 1 100 at ca. 526 nm in aqueous solution at pH 7 Description Red powder or granules. Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 526 nm at pH 7 Purity Inorganic iodides Not more than 0,1 % (calculated as sodium iodide) Water insoluble matter Not more than 0,2 % Subsidiary colouring matters (except fluorescein) Not more than 4,0 % Fluorescein Not more than 20 mg/kg Organic compounds other than colouring matters: Tri-iodoresorcinol Not more than 0,2 % 2-(2,4-dihydroxy-3,5-diiodobenzoyl) benzoic acid Not more than 0,2 % Ether extractable matter From a solution of pH from 7 through 8, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium Lakes of this colour may be used.

E 129 ALLURA RED AC







Synonyms CI Food Red 17 Definition Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4-methoxy-2-toluenesulphonic acid with 6-hydroxy-2-naphthalene sulphonic acid Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 16035 Einecs 247-368-0 Chemical name Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate Chemical formula C18H14N2Na2O8S2 Molecular weight 496,42 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 540 at ca. 504 nm in aqueous solution at pH 7 Description Dark red powder or granules Appearance of the aqueous solution Red Identification Spectrometry Maximum in water at ca. 504 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 3,0 % Organic compounds other than colouring matters: 6-hydroxy-2-naphthalene sulfonic acid, sodium salt Not more than 0,3 % 4-amino-5-methoxy-2-methylbenezene sulfonic acid Not more than 0,2 % 6,6-oxybis (2-naphthalene sulfonic acid) disodium salt Not more than 1,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter From a solution of pH 7, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 131 PATENT BLUE V







Synonyms CI Food Blue 5 Definition Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components. The potassium salt is also permitted. Colour Index No 42051 Einecs 222-573-8 Chemical name The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt Chemical formula Calcium compound: C27H31N2O7S2Ca1/2 Sodium compound: C27H31N2O7S2Na Molecular weight Calcium compound: 579,72 Sodium compound: 582,67 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 2 000 at ca. 638 nm in aqueous solution at pH 5 Description Dark blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at 638 nm at pH 5 Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 2,0 % Organic compounds other than colouring matters: 3-hydroxy benzaldehyde Total not more than 0,5 % 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Leuco base Not more than 4,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter From a solution of pH 5 not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 132 INDIGOTINE, INDIGO CARMINE







Synonyms CI Food Blue 1 Definition Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted. Indigo carmine is obtained by sulphonation of indigo. This is accomplished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures. Colour Index No 73015 Einecs 212-728-8 Chemical name Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate Chemical formula C16H8N2Na2O8S2 Molecular weight 466,36 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt; disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 % 480 at ca. 610 nm in aqueous solution Description Dark-blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at ca. 610 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 % Organic compounds other than colouring matters: Isatin-5-sulfonic acid Total not more than 0,5 % 5-sulfoanthranilic acid Anthranilic acid Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 133 BRILLIANT BLUE FCF







Synonyms CI Food Blue 2 Definition Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 42090 Einecs 223-339-8 Chemical name Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate Chemical formula C37H34N2Na2O9S3 Molecular weight 792,84 Assay Content not less than 85 % total colouring matters, calculated as the sodium salt 1 630 at ca. 630 nm in aqueous solution Description Reddish-blue powder or granules Appearance of the aqueous solution Blue Identification Spectrometry Maximum in water at ca. 630 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 6,0 % Organic compounds other than colouring matters: Sum of 2-, 3- and 4-formyl benzene sulfonic acids Not more than 1,5 % 3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid Not more than 0,3 % Leuco base Not more than 5,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % at pH 7 Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 140 (i) CHLOROPHYLLS







Synonyms CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeophytin Definition Chlorophylls are obtained by solvent extraction of strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present coordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Colour Index No 75810 Einecs Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4 Chemical name The major colouring principles are: Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a) Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b) Chemical formula Chlorophyll a (magnesium complex): C55H72MgN4O5 Chlorophyll a: C55H74N4O5 Chlorophyll b (magnesium complex): C55H70MgN4O6 Chlorophyll b: C55H72N4O6 Molecular weight Chlorophyll a (magnesium complex): 893,51 Chlorophyll a: 871,22 Chlorophyll b (magnesium complex): 907,49 Chlorophyll b: 885,20 Assay Content of total combined Chlorophylls and their magnesium complexes is not less than 10 % 700 at ca. 409 nm in chloroform Description Waxy solid ranging in colour from olive green to dark green depending on the content of coordinated magnesium Identification Spectrometry Maximum in chloroform at ca. 409 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 140 (ii) CHLOROPHYLLINS







Synonyms CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin Definition The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralised to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Colour Index No 75815 Einecs 287-483-3 Chemical name The major colouring principles in their acid forms are: — 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a) — and — 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b) Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function. Magnesium complexes may also be present. Chemical formula Chlorophyllin a (acid form): C34H34N4O5 Chlorophyllin b (acid form): C34H32N4O6 Molecular weight Chlorophyllin a: 578,68 Chlorophyllin b: 592,66 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Assay Content of total chlorophyllins is not less than 95 % of the sample dried at ca. 100 °C for 1 hour. 700 at ca. 405 nm in aqueous solution at pH 9 140 at ca. 653 nm in aqueous solution at pH 9 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and at ca. 653 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS







Synonyms CI Natural Green 3; Copper Chlorophyll; Copper Phaeophytin Definition Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane. Colour Index No 75810 Einecs Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5 Chemical name [Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a) [Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b) Chemical formula Copper chlorophyll a: C55H72Cu N4O5 Copper chlorophyll b: C55H70Cu N4O6 Molecular weight Copper chlorophyll a: 932,75 Copper chlorophyll b: 946,73 Assay Content of total copper chlorophylls is not less than 10 %. 540 at ca. 422 nm in chloroform 300 at ca. 652 nm in chloroform Description Waxy solid ranging in colour from blue green to dark green depending on the source material Identification Spectrometry Maximum in chloroform at ca. 422 nm and at ca. 652 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8,0 % of the total copper phaeophytins

Aluminium lakes of this colour may be used.

E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS







Synonyms Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5 Definition The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralised to form the salts of potassium and/or sodium. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane. Colour Index No 75815 Einecs Chemical name The major colouring principles in their acid forms are 3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b) Chemical formula Copper chlorophyllin a (acid form): C34H32Cu N4O5 Copper chlorophyllin b (acid form): C34H30Cu N4O6 Molecular weight Copper chlorophyllin a: 640,20 Copper chlorophyllin b: 654,18 Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved. Assay Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h. 565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5 145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5 Description Dark green to blue/black powder Identification Spectrometry Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and at 630 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Copper ions Not more than 200 mg/kg Total copper Not more than 8,0 % of the total copper chlorophyllins

Aluminium lakes of this colour may be used.

E 142 GREEN S







Synonyms CI Food Green 4, Brilliant Green BS Definition Green S consists essentially of sodium N-[4-[[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds. Green S is described as the sodium salt. The calcium and the potassium salt are also permitted. Colour Index No 44090 Einecs 221-409-2 Chemical name Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name). Chemical formula C27H25N2NaO7S2 Molecular weight 576,63 Assay Content not less than 80 % total colouring matters calculated as the sodium salt 1 720 at ca. 632 nm in aqueous solution Description Dark blue or dark green powder or granules Appearance of the aqueous solution Blue or green Identification Spectrometry Maximum in water at ca. 632 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 1,0 % Organic compounds other than colouring matters: 4,4′-bis(dimethylamino)-benzhydryl alcohol Not more than 0,1 % 4,4′-bis(dimethylamino)-benzophenone Not more than 0,1 % 3-hydroxynaphthalene-2,7-disulfonic acid Not more than 0,2 % Leuco base Not more than 5,0 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 150a PLAIN CARAMEL







Synonyms Caustic caramel Definition Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites. Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose Not more than 50 % Colour bound by phosphoryl cellulose Not more than 50 % Colour intensity (1) 0,01-0,12 Total nitrogen Not more than 0,1 % Total sulphur Not more than 0,2 % Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg ( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

E 150b CAUSTIC SULPHITE CARAMEL







Synonyms Definition Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used. Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose More than 50 % Colour intensity (1) 0,05-0,13 Total nitrogen Not more than 0,3 % (2) Sulphur dioxide Not more than 0,2 % (2) Total sulphur 0,3-3,5 % (2) Sulphur bound by DEAE cellulose More than 40 % Absorbance ratio of colour bound by DEAE cellulose 19-34 Absorbance ratio (A 280/560) Greater than 50 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg ( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. ( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

E 150c AMMONIA CARAMEL







Synonyms Definition Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used. Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose Not more than 50 % Colour bound by phosphoryl cellulose More than 50 % Colour intensity (1) 0,08-0,36 Ammoniacal nitrogen Not more than 0,3 % (2) 4-methylimidazole Not more than 200 mg/kg (2) 2-acetyl-4-tetrahydroxy-butylimidazole Not more than 10 mg/kg (2) Total sulphur Not more than 0,2 % (2) Total nitrogen 0,7-3,3 % (2) Absorbance ratio of colour bound by phosphoryl cellulose 13-35 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg ( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. ( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

E 150d SULPHITE AMMONIA CARAMEL







Synonyms Definition Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite). Colour Index No Einecs 232-435-9 Chemical name Chemical formula Molecular weight Assay Description Dark brown to black liquids or solids Identification Purity Colour bound by DEAE cellulose More than 50 % Colour intensity (1) 0,10-0,60 Ammoniacal nitrogen Not more than 0,6 % (2) Sulphur dioxide Not more than 0,2 % (2) 4-methylimidazole Not more than 250 mg/kg (2) Total nitrogen 0,3-1,7 % (2) Total sulphur 0,8-2,5 % (2) Nitrogen/sulphur ratio of alcohol precipitate 0,7-2,7 Absorbance ratio of alcohol precipitate (3) 8-14 Absorbance ratio (A 280/560) Not more than 50 Arsenic Not more than 1 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg ( 1 ) Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm. ( 2 ) Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. ( 3 ) Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).

▼M8

E 151 BRILLIANT BLACK PN

▼B







Synonyms CI Food Black 1 ▼M8 Definition Brilliant Black PN consists essentially of tetrasodium-4-acetamido-5- hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Brilliant Black PN is described as the sodium salt. The calcium and the potassium salt are also permitted. ▼B Colour Index No 28440 Einecs 219-746-5 Chemical name Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate Chemical formula C28H17N5Na4O14S4 Molecular weight 867,69 Assay Content not less than 80 % total colouring matters calculated as the sodium salt 530 at ca. 570 nm in solution Description Black powder or granules Appearance of the aqueous solution Black-bluish Identification Spectrometry Maximum in water at ca. 570 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 4 % (expressed on the dye content) Organic compounds other than colouring matters: 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid Total not more than 0,8 % 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid 8-aminonaphthalene-2-sulfonic acid 4,4′-diazoaminodi-(benzenesulfonic acid) Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % under neutral conditions Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 153 VEGETABLE CARBON







Synonyms Vegetable black Definition Vegetable activated carbon is produced by the carbonisation of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The activated carbon thus produced is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fractio40800n from the cyclone is purified by hydrochloric acid washing, neutralised and then dried. The resulting product is what is known traditionally as vegetable black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing, neutralising and drying. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture. Colour Index No 77266 Einecs 231-153-3 Chemical name Carbon Chemical formula C Atomic weight 12,01 Assay Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis Loss on drying Not more than 12 % (120 °C 4 h) Description Black, odourless powder Identification Solubility Insoluble in water and organic solvents Burning When heated to redness it burns slowly without a flame Purity Ash (Total) Not more than 4,0 % (ignition temperature: 625 °C) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Polycyclic aromatic hydrocarbons Benzo(a)pyrene less than 50 μg/kg in the extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction. Alkali soluble matter The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

E 155 BROWN HT







Synonyms CI Food Brown 3 Definition Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components. Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted. Colour Index No 20285 Einecs 224-924-0 Chemical name Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate) Chemical formula C27H18N4Na2O9S2 Molecular weight 652,57 Assay Content not less than 70 % total colouring matters calculated as the sodium salt. 403 at ca. 460 nm in aqueous solution at pH 7 Description Reddish-brown powder or granules Appearance of the aqueous solution Brown Identification Spectrometry Maximum in water of pH 7 at ca. 460 nm Purity Water insoluble matter Not more than 0,2 % Subsidiary colouring matters Not more than 10 % (TLC method) Organic compounds other than colouring matters: 4-aminonaphthalene- 1-sulfonic acid Not more than 0,7 % Unsulfonated primary aromatic amines Not more than 0,01 % (calculated as aniline) Ether extractable matter Not more than 0,2 % in a solution of pH 7 Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 160 a (i) BETA-CAROTENE







Synonyms CI Food Orange 5 Definition These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios. Colour Index No 40800 Einecs 230-636-6 Chemical name Beta-carotene; beta, beta-carotene Chemical formula C40H56 Molecular weight 536,88 Assay Not less than 96 % total colouring matters (expressed as beta-carotene) 2 500 at approximately by 440 nm to 457 nm in cyclohexane Description Red to brownish-red crystals or crystalline powder Identification Spectrometry Maximum in cyclohexane at 453 nm to 456 nm Purity Sulphated ash Not more than 0,1 % Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead Not more than 2 mg/kg

E 160 a (ii) PLANT CAROTENES







Synonyms CI Food Orange 5 Definition Plant carotenes are obtained by solvent extraction of strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle. The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (1), dichloromethane and carbon dioxide. Colour Index No 75130 Einecs 230-636-6 Chemical name Chemical formula Beta-carotene: C40H56 Molecular weight Beta-carotene: 536,88 Assay Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats 2 500 at approximately 440 nm to 457 nm in cyclohexane Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Propan-2-ol Hexane Ethanol Dichloromethane Not more than 10 mg/kg Lead Not more than 2 mg/kg ( 1 ) Benzene not more than 0,05 % v/v.

E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora







Synonyms CI Food Orange 5 Definition Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate or isobutyl acetate followed by propan-2-ol and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product. Colour Index No 40800 Einecs 230-636-6 Chemical name Beta-carotene; beta, beta-carotene Chemical formula C40H56 Molecular weight 536,88 Assay Not less than 96 % total colouring matters (expressed as beta-carotene) 2 500 at approximately 440 nm to 457 nm in cyclohexane Description Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation) Identification Spectrometry Maximum in cyclohexane at 453 nm to 456 nm Purity Solvent residues Ethyl acetate Not more than 0,8 %, singly or in combination Ethanol Isobutyl acetate: Not more than 1,0 % Propan-2-ol: Not more than 0,1 % Sulphated ash Not more than 0,2 % Subsidiary colouring matters Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters Lead Not more than 2 mg/kg Microbiological criteria Moulds Not more than 100 colonies per gram Yeasts Not more than 100 colonies per gram Salmonella spp. Absent in 25 g Escherichia coli Absent in 5 g

E 160 a (iv) ALGAL CAROTENES







Synonyms CI Food Orange 5 ▼M8 Definition Mixed carotenes may also be produced from strains of the algae Dunaliella salina. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29. The main colouring principle consists of carotenoids of which beta- carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material. ▼B Colour Index No 75130 Einecs Chemical name Chemical formula Beta-Carotene: C40H56 Molecular weight Beta-Carotene: 536,88 Assay Content of carotenes (calculated as beta-carotene) is not less than 20 % 2 500 at approximately by 440 nm to 457 nm in cyclohexane Description Identification Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm Purity Natural tocopherols in edible oil Not more than 0,3 % Lead Not more than 2 mg/kg

▼M32

E 160 b (i) ANNATTO BIXIN

(I) SOLVENT-EXTRACTED BIXIN







Synonyms Annatto B, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 Definition Solvent-extracted bixin is obtained by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following food grade solvents: acetone, methanol, hexane, ethanol, isopropyl alcohol, ethyl acetate, alkaline alcohol or supercritical carbon dioxide. The resulting preparation may be acidified, followed by the removal of the solvent, drying and milling. Solvent-extracted bixin contains several coloured components; the major colouring principle is cis-bixin, a minor colouring principle is trans-bixin; thermal degradation products of bixin may also be present as a result of processing. Colour Index No 75120 Einecs 230-248-7 Chemical name cis-Bixin: Methyl (9-cis)-hydrogen-6,6'-diapo-Ψ,Ψ-carotenedioate Chemical formula cis-Bixin: C25H30O4 Molecular weight 394,5 Assay Not less than 85 % colouring matter (expressed as bixin) E1 % 1cm 3090 at ca. 487 nm in tetrahydrofuran and acetone Description Dark red-brown to red-purple powder Identification Solubility Insoluble in water, slightly soluble in ethanol Spectrometry The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm Purity Norbixin Not more than 5 % of total colouring matters Residual Solvents Acetone: Not more than 30 mg/kg Methanol: Not more than 50 mg/kg Hexane: Not more than 25 mg/kg Ethanol: Isopropyl alcohol: Ethyl acetate: not more than 50 mg/kg, singly or in combination Arsenic Not more than 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 0,5 mg/kg

(II) AQUEOUS-PROCESSED BIXIN







Synonyms Annatto E, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 Definition Aqueous-processed bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) by abrading the seeds in the presence of cold, mildly-alkaline water. The resultant preparation is acidified to precipitate bixin which is then filtered, dried and milled. Aqueous-processed bixin contains several coloured components; the major colouring principle is cis-bixin, a minor colouring principle is trans-bixin; thermal degradation products of bixin may also be present as a result of processing. Colour Index No 75120 Einecs 230-248-7 Chemical name cis-Bixin: Methyl (9-cis)-hydrogen-6,6'-diapo-Ψ,Ψ-carotenedioate Chemical formula cis-Bixin: C25H30O4 Molecular weight 394,5 Assay Not less than 25 % colouring matter (expressed as bixin) E1 % 1cm 3090 at ca. 487 nm in tetrahydrofuran and acetone Description Dark red-brown to red-purple powder Identification Solubility Insoluble in water, slightly soluble in ethanol Spectrometry The sample in acetone shows absorbance maxima at about 425, 457 and 487 nm Purity Norbixin Not more than 7 % of total colouring matters Arsenic Not more than 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 0,5 mg/kg

E 160 b (ii) ANNATTO NORBIXIN

(I) SOLVENT-EXTRACTED NORBIXIN







Synonyms Annatto C, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 Definition Solvent-extracted norbixin is obtained from the outer coating of the seeds of the annatto tree (Bixa orellana L.) by washing with one or more of the following food grade solvents: acetone, methanol, hexane, ethanol, isopropyl alcohol, ethyl acetate, alkaline alcohol or supercritical carbon dioxide followed by solvent removal, crystallization and drying. Aqueous alkali is added to the resultant powder, which is then heated to hydrolyse the colouring matter and cooled. The aqueous solution is filtered, and acidified to precipitate the norbixin. The precipitate is filtered, washed, dried and milled, to give a granular powder. Solvent-extracted norbixin contains several coloured components; the major colouring principle is cis-norbixin, a minor colouring principle is trans-norbixin; thermal degradation products of norbixin may also be present as a result of processing. Colour Index No 75120 Einecs 208-810-8 Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-carotenedioic acid cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carotenedioate cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carotenedioate Chemical formula cis-Norbixin: C24H28O4 cis-Norbixin dipotassium salt: C24H26K2O4 cis-Norbixin disodium salt: C24H26Na2O4 Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) Assay Not less than 85 % colouring matter (expressed as norbixin) E1 % 1cm 2870 at ca. 482 nm in 0,5 % potassium hydroxide solution Description Dark red-brown to red-purple powder Identification Solubility Soluble in alkaline water, slightly soluble in ethanol Spectrometry The sample in 0,5 % potassium hydroxide solution shows absorbance maxima at about 453 nm and 482 nm Purity Residual Solvents Acetone: Not more than 30 mg/kg Methanol: Not more than 50 mg/kg Hexane: Not more than 25 mg/kg Ethanol: Isopropyl alcohol: Ethyl acetate: not more than 50 mg/kg, singly or in combination Arsenic Not more than 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 0,5 mg/kg

(II) ALKALI-PROCESSED NORBIXIN, ACID-PRECIPITATED







Synonyms Annatto F, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 Definition Alkali-processed norbixin (acid-precipitated) is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with aqueous alkali. The bixin is hydrolysed to norbixin in hot alkaline solution and is acidified to precipitate the norbixin. The precipitate is filtered, dried and milled to give a granular powder. Alkali-processed norbixin contains several coloured components; the major colouring principle is cis-norbixin, a minor colouring principle is trans-norbixin; thermal degradation products of norbixin may also be present as a result of processing. Colour Index No 75120 Einecs 208-810-8 Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-carotenedioic acid cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carotenedioate cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carotenedioate Chemical formula cis-Norbixin: C24H28O4 cis-Norbixin dipotassium salt: C24H26K2O4 cis-Norbixin disodium salt: C24H26Na2O4 Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) Assay Not less than 35 % colouring matter (expressed as norbixin) E1 % 1cm 2870 at ca. 482 nm in 0,5 % potassium hydroxide solution Description Dark red-brown to red-purple powder Identification Solubility Soluble in alkaline water, slightly soluble in ethanol Spectrometry The sample in 0,5 % potassium hydroxide solution shows absorbance maxima at about 453 nm and 482 nm Purity Arsenic Not more than 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 0,5 mg/kg

(III) ALKALI-PROCESSED NORBIXIN, NOT ACID-PRECIPITATED







Synonyms Annatto G, Orlean, Terre orellana, L. Orange, CI Natural Orange 4 Definition Alkali-processed norbixin (not acid-precipitated) is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with aqueous alkali. The bixin is hydrolysed to norbixin in hot alkaline solution. The precipitate is filtered, dried and milled to give a granular powder. Extracts contain mainly the potassium or sodium salt of norbixin as the major colouring matter. Alkali-processed norbixin (not acid-precipitated) contains several coloured components; the major colouring principle is cis-norbixin, a minor colouring principle is trans-norbixin; thermal degradation products of norbixin may also be present as a result of processing. Colour Index No 75120 Einecs 208-810-8 Chemical name cis-Norbixin: 6,6'-Diapo-Ψ,Ψ-carotenedioic acid cis-Norbixin dipotassium salt: Dipotassium 6,6'-diapo-Ψ,Ψ-carotenedioate cis-Norbixin disodium salt: Disodium 6,6'-diapo-Ψ,Ψ-carotenedioate Chemical formula cis-Norbixin: C24H28O4 cis-Norbixin dipotassium salt: C24H26K2O4 cis-Norbixin disodium salt: C24H26Na2O4 Molecular weight 380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt) Assay Not less than 15 % colouring matter (expressed as norbixin) E1 % 1cm 2870 at ca. 482 nm in 0,5 % potassium hydroxide solution Description Dark red-brown to red-purple powder Identification Solubility Soluble in alkaline water, slightly soluble in ethanol Spectrometry The sample in 0,5 % potassium hydroxide solution shows absorbance maxima at about 453 nm and 482 nm Purity Arsenic Not more than 2 mg/kg Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 0,5 mg/kg

▼B

E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN







Synonyms Paprika Oleoresin Definition Paprika extract is obtained by solvent extraction of the strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present. Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate, propan-2-ol and carbon dioxide. Colour Index No Einecs Capsanthin: 207-364-1, capsorubin: 207-425-2 Chemical name Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,κ-carotene-6-one Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-κ,κ-carotene-6,6′-dione Chemical formula Capsanthin: C40H56O3 Capsorubin: C40H56O4 Molecular weight Capsanthin: 584,85 Capsorubin: 600,85 Assay Paprika extract: content not less than 7,0 % carotenoids Capsanthin/capsorubin: not less than 30 % of total carotenoids 2 100 at ca. 462 nm in acetone Description Dark-red viscous liquid Identification Spectrometry Maximum in acetone at ca. 462 nm Colour reaction A deep blue colour is produced by adding one drop of sulphuric acid to one drop of sample in 2-3 drops of chloroform Purity Solvent residues Ethyl acetate Not more than 50 mg/kg, singly or in combination Methanol Ethanol Acetone Hexane Propan-2-ol Dichloromethane: not more than 10 mg/kg Capsaicin Not more than 250 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 160 d LYCOPENE

(i) SYNTHETIC LYCOPENE







Synonyms Lycopene from chemical synthesis Definition Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of all-trans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder. Colour Index No 75125 Einecs 207-949-1 Chemical name ψ,ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay Not less than 96 % total lycopenes (not less than 70 % all-trans-lycopene) at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 Description Red crystalline powder Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm Test for carotenoids The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid Solubility Insoluble in water, freely soluble in chloroform Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour Purity Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg) Apo-12’-lycopenal Not more than 0,15 % Triphenyl phosphine oxide Not more than 0,01 % Solvent residues Methanol not more than 200 mg/kg, Hexane, Propan-2-ol: Not more than 10 mg/kg each. Dichloromethane: Not more than 10 mg/kg (in commercial preparations only) Lead Not more than 1 mg/kg

(ii) LYCOPENE FROM RED TOMATOES







Synonyms Natural Yellow 27 Definition Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The major colouring principle of tomatoes is lycopene; minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes. Colour Index No 75125 Einecs 207-949-1 Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 . Content not less than 5 % total colouring matters Description Dark red viscous liquid Identification Spectrophotometry Maximum in hexane at ca. 472 nm Purity Solvent residues Propan-2-ol Not more than 50 mg/kg, singly or in combination Hexane Acetone Ethanol Methanol Ethylacetate Sulphated ash Not more than 1 % Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg

(iii) LYCOPENE FROM BLAKESLEA TRISPORA







Synonyms Natural Yellow 27 Definition Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallisation and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carotenoids. Propan-2-ol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder. Colour Index No 75125 Einecs 207-949-1 Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene Chemical formula C40H56 Molecular weight 536,85 Assay Not less than 95 % total lycopenes and not less than 90 % all-trans-lycopene of all colouring matters at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 Description Red crystalline powder Identification Spectrophotometry A solution in hexane shows an absorption maximum at approximately 470 nm Test of carotenoids The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid Solubility Insoluble in water, freely soluble in chloroform Properties of 1 % solution in chloroform Is clear and has intensive red-orange colour Purity Loss on drying Not more than 0,5 % (40 °C, 4 h at 20 mm Hg) Other carotenoids Not more than 5 % Solvent residues Propan-2-ol: not more than 0,1 % Isobutyl acetate: not more than 1,0 % Dichloromethane: not more than 10 mg/kg (in commercial preparations only) Sulphated ash Not more than 0,3 % Lead Not more than 1 mg/kg

E 160 e BETA-APO-8′-CAROTENAL (C30)







Synonyms CI Food Orange 6 Definition These specifications apply predominantly to the all-trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Colour Index No 40820 Einecs 214-171-6 Chemical name β-Apo-8′-carotenal; trans-β-Apo-8′carotene-aldehyde Chemical formula C30H40O Molecular weight 416,65 Assay Not less than 96 % of total colouring matters 2 640 at 460-462 nm in cyclohexane Description Dark violet crystals with metallic lustre or crystalline powder Identification Spectrometry Maximum in cyclohexane at 460-462 nm Purity Sulphated ash Not more than 0,1 % Subsidiary colouring matters Carotenoids other than β-apo-8′-carotenal: not more than 3,0 % of total colouring matters Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 161 b LUTEIN







Synonyms Mixed Carotenoids; Xanthophylls Definition Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material. Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide Colour Index No Einecs 204-840-0 Chemical name 3,3′-dihydroxy-d-carotene Chemical formula C40H56O2 Molecular weight 568,88 Assay Content of total colouring matter not less than 4 % calculated as lutein 2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10) Description Dark, yellowish brown liquid Identification Spectrometry Maximum in chloroform/ethanol (1:9) at ca. 445 nm Purity Solvent residues Acetone Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Arsenic Not more than 3 mg/kg Lead Not more than 3 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 161g CANTHAXANTHIN







Synonyms CI Food Orange 8 Definition These specifications apply to predominantly all-trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios. Colour Index No 40850 Einecs 208-187-2 Chemical name β-Carotene-4,4′-dione; canthaxanthin; 4,4′-dioxo-β-carotene Chemical formula C40H52O2 Molecular weight 564,86 Assay Not less than 96 % of total colouring matters (expressed as canthaxanthin) 2 200 at ca. 485 nm in chloroform at 468-472 nm in cyclohexane at 464-467 nm in petroleum ether Description Deep violet crystals or crystalline powder Identification Spectrometry Maximum in chloroform at ca. 485 nm Maximum in cyclohexane at 468-472 nm Maximum in petroleum ether at 464-467 nm Purity Sulphated ash Not more than 0,1 % Subsidiary colouring matters Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 162 BEETROOT RED, BETANIN







Synonyms Beet Red Definition Beet red is obtained from the roots of strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present. Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins. Colour Index No Einecs 231-628-5 Chemical name (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate Chemical formula Betanin: C24H26N2O13 Molecular weight 550,48 Assay Content of red colour (expressed as betanine) is not less than 0,4 % 1 120 at ca. 535 nm in aqueous solution at pH 5 Description Red or dark red liquid, paste, powder or solid Identification Spectrometry Maximum in water of pH 5 at ca. 535 nm Purity Nitrate Not more than 2 g nitrate anion/g of red colour (as calculated from assay). Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 163 ANTHOCYANINS







Synonyms Definition Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units. Colour Index No Einecs 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin) Chemical name 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin) 3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin) 3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin) 3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin) 3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin) 3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin) Chemical formula Cyanidin: C15H11O6Cl Peonidin: C16H13O6Cl Malvidin: C17H15O7Cl Delphinidin: C15H11O7Cl Petunidin: C16H13O7Cl Pelargonidin: C15H11O5Cl Molecular weight Cyanidin: 322,6 Peonidin: 336,7 Malvidin: 366,7 Delphinidin: 340,6 Petunidin: 352,7 Pelargonidin: 306,7 Assay 300 for the pure pigment at 515-535 nm at pH 3,0 Description Purplish-red liquid, powder or paste, having a slight characteristic odour Identification Spectrometry Maximum in methanol with 0,01 % conc. HCl Cyanidin: 535 nm Peonidin: 532 nm Malvidin: 542 nm Delphinidin: 546 nm Petunidin: 543 nm Pelargonidin: 530 nm Purity Solvent residues Methanol Not more than 50 mg/kg Ethanol Not more than 200 mg/kg Sulfur dioxide Not more than 1 000 mg/kg per percent pigment Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 170 CALCIUM CARBONATE







Synonyms CI Pigment White 18; Chalk Definition Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions. Colour Index No 77220 Einecs Calcium carbonate: 207-439-9 Limestone: 215-279-6 Chemical name Calcium carbonate Chemical formula CaCO3 Molecular weight 100,1 Assay Content not less than 98 % on the anhydrous basis Description White crystalline or amorphous, odourless and tasteless powder Identification Solubility Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium. Purity Loss on drying Not more than 2,0 % (200 °C, 4 hours) Acid-insoluble substances Not more than 0,2 % Magnesium and alkali salts Not more than 1 % Fluoride Not more than 50 mg/kg Antimony (as Sb) Not more than 100 mg/kg, singly or in combination Copper (as Cu) Chromium (as Cr) Zinc (as Zn) Barium (as Ba) Arsenic Not more than 3 mg/kg Lead Not more than 3 mg/kg Cadmium Not more than 1 mg/kg

E 171 TITANIUM DIOXIDE







Synonyms CI Pigment White 6 Definition Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product. The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process. Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process. Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide. Colour Index No 77891 Einecs 236-675-5 Chemical name Titanium dioxide Chemical formula TiO2 Molecular weight 79,88 Assay Content not less than 99 % on an alumina and silica-free basis Description White to slightly coloured powder Identification Solubility Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid. Purity Loss on drying Not more than 0,5 % (105 °C, 3 hours) Loss on ignition Not more than 1,0 % on a volatile matter free basis (800 °C) Aluminium oxide and/or silicon dioxide Total not more than 2,0 % Matter soluble in 0,5 N HCl Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold. Water soluble matter Not more than 0,5 % Cadmium Not more than 1 mg/kg after an extraction with 0,5 N HCl. Antimony Not more than 2 mg/kg after an extraction with 0,5 N HCl. Arsenic Not more than 1 mg/kg after an extraction with 0,5 N HCl. Lead Not more than 10 mg/kg after an extraction with 0,5 N HCl. Mercury Not more than 1 mg/kg after an extraction with 0,5 N HCl.

E 172 IRON OXIDES AND IRON HYDROXIDES







Synonyms Iron Oxide Yellow: CI Pigment Yellow 42 and 43 Iron Oxide Red: CI Pigment Red 101 and 102 Iron Oxide Black: CI Pigment Black 11 Definition Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process. Colour Index No Iron Oxide Yellow: 77492 Iron Oxide Red: 77491 Iron Oxide Black: 77499 Einecs Iron Oxide Yellow: 257-098-5 Iron Oxide Red: 215-168-2 Iron Oxide Black: 235-442-5 Chemical name Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide Chemical formula Iron Oxide Yellow: FeO(OH) · H2O Iron Oxide Red: Fe2O3 Iron Oxide Black: FeO.Fe2O3 Molecular weight 88,85: FeO(OH) 159,70: Fe2O3 231,55: FeO.Fe2O3 Assay Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron Description Powder; yellow, red, brown or black in hue Identification Solubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids Purity Water soluble matter Not more than 1,0 % By total dissolution Arsenic Not more than 3 mg/kg Cadmium Not more than 1 mg/kg Chromium Not more than 100 mg/kg Copper Not more than 50 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Nickel Not more than 200 mg/kg Zinc Not more than 100 mg/kg

E 173 ALUMINIUM







Synonyms CI Pigment Metal Definition Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids. Colour Index No 77000 Einecs 231-072-3 Chemical name Aluminium Chemical formula Al Atomic weight 26,98 Assay Not less than 99 % calculated as Al on an oil-free basis Description A silvery-grey powder or tiny sheets Identification Solubility Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. Test for aluminium A sample dissolved in dilute hydrochloric acid passes test Purity Loss on drying Not more than 0,5 % (105 °C, to constant weight) Arsenic Not more than 3 mg/kg Lead Not more than 10 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

E 174 SILVER







Synonyms Argentum Definition Colour Index No 77820 Einecs 231-131-3 Chemical name Silver Chemical formula Ag Atomic weight 107,87 Assay Content not less than 99,5 % Ag Description Silver-coloured powder or tiny sheets Identification Purity

E 175 GOLD







Synonyms Pigment Metal 3; Aurum Definition Colour Index No 77480 Einecs 231-165-9 Chemical name Gold Chemical formula Au Atomic weight 197,0 Assay Content not less than 90 % Au Description Gold-coloured powder or tiny sheets Identification Purity Silver Not more than 7 % After complete dissolution Copper Not more than 4 %

E 180 LITHOLRUBINE BK







Synonyms CI Pigment Red 57; Rubinpigment; Carmine 6B Definition Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components. Colour Index No 15850:1 Einecs 226-109-5 Chemical name Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate Chemical formula C18H12CaN2O6S Molecular weight 424,45 Assay Content not less than 90 % total colouring matters 200 at ca. 442 nm in dimethylformamide Description Red powder Identification Spectrometry Maximum in dimethylformamide at ca. 442 nm Purity Subsidiary colouring matters Not more than 0,5 % Organic compounds other than colouring matters: 2-Amino-5-methylbenzenesulfonic acid, calcium salt Not more than 0,2 % 3-hydroxy-2-naphthalenecarboxylic acid, calcium salt Not more than 0,4 % Unsulfonated primary aromatic amines Not more than 0,01 % (expressed as aniline) Ether extractable matter From a solution of pH 7, not more than 0,2 % Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg

Aluminium lakes of this colour may be used.

E 200 SORBIC ACID







Synonyms Definition Einecs 203-768-7 Chemical name Sorbic acid; trans, trans-2,4-Hexadienoic acid Chemical formula C6H8O2 Molecular weight 112,12 Assay Content not less than 99 % on the anhydrous basis Description Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C Identification Melting range Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator Spectrometry A propan-2-ol solution (1 in 4 000 000 ) shows absorbance maximum at 254 ± 2 nm Test for double bonds Passes test Solubility Slightly soluble in water, soluble in ethanol. Purity Water content Not more than 0,5 % (Karl Fischer method) Sulphated ash Not more than 0,2 % Aldehydes Not more than 0,1 % (as formaldehyde) Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 202 POTASSIUM SORBATE







Synonyms Definition Einecs 246-376-1 Chemical name Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid Chemical formula C6H7O2K Molecular weight 150,22 Assay Content not less than 99 % on the dried basis Description White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C Identification Melting range for sorbic acid Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator Test for potassium Passes test Test for double bonds Passes test Purity Loss on drying Not more than 1,0 % (105 °C, 3 hours) Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3) Aldehydes Not more than 0,1 %, calculated as formaldehyde Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

▼M25 —————

▼B

E 210 BENZOIC ACID







Synonyms Definition Einecs 200-618-2 Chemical name Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid Chemical formula C7H6O2 Molecular weight 122,12 Assay Content not less than 99,5 % on the anhydrous basis Description White crystalline powder Identification Melting range 121,5 °C -123,5 °C Sublimation test Passes test Test for benzoate Passes test pH About 4 (solution in water) Purity Loss on drying Not more than 0,5 % (3 hours, over sulphuric acid) Sulphated ash Not more than 0,05 % Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3) and 4,4 ml of water Polycyclic acids On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg ( 1 ) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml. ( 2 ) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml. ( 3 ) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*1). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml. ( *1 ) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.

E 211 SODIUM BENZOATE







Synonyms Definition Einecs 208-534-8 Chemical name Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid Chemical formula C7H5O2Na Molecular weight 144,11 Assay Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours Description A white, almost odourless, crystalline powder or granules Identification Solubility Freely soluble in water, sparingly soluble in ethanol Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator Test for benzoate Passes test Test for sodium Passes test Purity Loss on drying Not more than 1,5 % (105 °C, 4 hours) Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Polycyclic acids On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Acidity or alkalinity Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 212 POTASSIUM BENZOATE







Synonyms Definition Einecs 209-481-3 Chemical name Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid Chemical formula C7H5KO2·3H2O Molecular weight 214,27 Assay Content not less than 99 % C7H5KO2 after drying at 105 °C to constant weight Description White crystalline powder Identification Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator Test for benzoate Passes test Test for potassium Passes test Purity Loss on drying Not more than 26,5 % (105 °C, 4 hours) Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water Polycyclic acids On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid Acidity or alkalinity Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 213 CALCIUM BENZOATE







Synonyms Monocalcium benzoate Definition Einecs 218-235-4 Chemical name Calcium benzoate; Calcium dibenzoate Chemical formula Anhydrous: C14H10O4Ca Monohydrate: C14H10O4Ca·H2O Trihydrate: C14H10O4Ca·3H2O Molecular weight Anhydrous: 282,31 Monohydrate: 300,32 Trihydrate: 336,36 Assay Content not less than 99 % after drying at 105 °C Description White or colourless crystals, or white powder Identification Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator Test for benzoate Passes test Test for calcium Passes test Purity Loss on drying Not more than 17,5 % (105 °C, to constant weight) Water insoluble matter Not more than 0,3 % Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Readily carbonisable substances Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water Polycyclic acids On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid Acidity or alkalinity Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 214 ETHYL p-HYDROXYBENZOATE







Synonyms Ethylparaben; Ethyl p-oxybenzoate Definition Einecs 204-399-4 Chemical name Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid Chemical formula C9H10O3 Molecular weight 166,8 Assay Content not less than 99,5 % after drying for two hours at 80 °C Description Almost odourless, small, colourless crystals or a white, crystalline powder Identification Melting range 115-118 °C Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator Test for alcohol Passes test Purity Loss on drying Not more than 0,5 % (80 °C, 2 hours) Sulphated ash Not more than 0,05 % p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE







Synonyms Definition Einecs 252-487-6 Chemical name Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid Chemical formula C9H9O3Na Molecular weight 188,8 Assay Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis Description White, crystalline hygroscopic powder Identification Melting range 115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator Test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C Test for sodium Passes test pH 9,9-10,3 (0,1 % aqueous solution) Purity Loss on drying Not more than 5 %, (by vacuum drying in a sulphuric