Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version)Text with EEA relevance

Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (Codified version) (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption OJ L 40, 11.2.1989, p. 27. , and in particular Article 3(3)(a) thereof, Whereas: (1) Commission Directive 95/45/EC of 26 July 1995 laying down specific criteria concerning colours for use in foodstuffs OJ L 226, 22.9.1995, p. 1. has been substantially amended several times See Annex II, Part A. . In the interests of clarity and rationality the said Directive should be codified. (2) It is necessary to establish purity criteria for all colours mentioned in European Parliament and Council Directive 94/36/EC of 30 June 1994 on colours for use in foodstuffs OJ L 237, 10.9.1994, p. 13. . (3) It is necessary to take into account the specifications and analytical techniques for colours as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). (4) Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria. (5) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (6) This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B, HAS ADOPTED THIS DIRECTIVE:

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for colours mentioned in Directive 94/36/EC are set out in Annex I hereto.

Article 2

Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B. References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3

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

Article 4

This Directive is addressed to the Member States. Done at Brussels, 22 December 2008. For the Commission The President José Manuel Barroso

Annex

ANNEX I A. GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURS DefinitionAluminium 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 sulfate 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 matterNot more than 0,5 %Ether extractable matter

Not more than 0,2 % (under neutral conditions) Specific purity criteria for the corresponding colours are applicable. B. SPECIFIC CRITERIA OF PURITY 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. Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units. 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). Benzene not more than 0,05 % v/v. E 100 CURCUMINSynonymsCI Natural Yellow 3, Turmeric Yellow, Diferoyl MethaneDefinition Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of natural strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallisation. 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 occuring in turmeric may be present. Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane. ClassDicinnamoylmethaneColour Index No75300Einecs207-280-5Chemical names 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 E1 cm1 %1607 at ca 426 nm in ethanol DescriptionOrange-yellow crystalline powderIdentification A. Spectrometry Maximum in ethanol at ca 426 nm B. Melting Range 179 °C-182 °C PuritySolvent residues Ethylacetate Acetone n-butanol Methanol Ethanol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 101 (i) RIBOFLAVINSynonymsLactoflavinClassIsoalloxazineEinecs201-507-1Chemical names 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 formulaC17H20N4O6Molecular weight376,37Assay Content not less than 98 % on the anhydrous basis E1 cm1 % 328 at ca 444 nm in aqueous solution DescriptionYellow to orange-yellow crystalline powder, with slight odourIdentification A. Spectrometry The ratio A375/A267 is between 0,31 and 0,33 The ratio A444/A267 is between 0,36 and 0,39 in aqueous solutionMaximum in water at ca 444 nm B. Specific rotation [α]D20 between – 115° and – 140° in a 0,05 N sodium hydroxide solutionPurityLoss on dryingNot more than 1,5 % after drying at 105 °C for 4 hrsSulfated ashNot more than 0,1 %Primary aromatic aminesNot more than 100 mg/kg (calculated as aniline)ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 101 (ii) RIBOFLAVIN-5′-PHOSPHATESynonymsRiboflavin-5′-phosphate sodiumDefinitionThese specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate

ClassIsoalloxazineEinecs204-988-6Chemical names 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 formulaFor the dihydrate formC17H20N4NaO9P·2H2OFor the anhydrous formC17H20N4NaO9PMolecular weight541,36Assay Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2O E1 cm1 % 250 at ca 375 nm in aqueous solution DescriptionYellow to orange crystalline hygroscopic powder, with slight odour and a bitter tasteIdentification A. Spectrometry The ratio A375/A267 is between 0,30 and 0,34 The ratio A444/A267 is between 0,35 and 0,40 in aqueous solutionMaximum in water at ca 444 nm B. Specific rotation [α]D20 between + 38° and + 42° in a 5 molar HCl solutionPurityLoss on dryingNot more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate formSulfated ashNot more than 25 %Inorganic phosphateNot more than 1,0 % (calculated as PO4 on the anhydrous basis)Subsidiary colouring mattersRiboflavin (free)Not more than 6 %Riboflavine diphosphateNot more than 6 %Primary aromatic aminesNot more than 70 mg/kg (calculated as aniline)ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 102 TARTRAZINESynonymsCI Food Yellow 4Definition 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 sulfate as the principal uncoloured components. Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No19140Einecs217-699-5Chemical namesTrisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylateChemical formulaC16H9N4Na3O9S2 Molecular weight534,37Assay Content not less than 85 % total colouring matters calculated as the sodium salt E1 cm1 % 530 at ca 426 nm in aqueous solution DescriptionLight orange powder or granulesIdentification A. Spectrometry Maximum in water at ca 426 nm B. Yellow solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 1,0 % Organic compounds other than colouring matters: 4-hydrazinobenzene sulfonic acid 4-aminobenzene-1-sulfonic acid 5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid 4,4′-diazoaminodi(benzene sulfonic acid) Tetrahydroxysuccinic acid Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 104 QUINOLINE YELLOWSynonymsCI Food Yellow 13Definition Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-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 sulfate as the principal uncoloured components.

Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassChinophthaloneColour Index No47005Einecs305-897-5Chemical nameThe disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)Chemical formulaC18H9N Na2O8S2 (principal component)Molecular weight477,38 (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 E1 cm1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution DescriptionYellow powder or granulesIdentification A. Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm B. Yellow solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 4,0 % Organic compounds other than colouring matters: 2-methylquinoline 2-methylquinoline-sulfonic acid Phthalic acid 2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid Total not more than 0,5 %2-(2-quinolyl)indan-1,3-dioneNot more than 4 mg/kgUnsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 110 SUNSET YELLOW FCFSynonymsCI Food Yellow 3, Orange Yellow SDefinition 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 sulfate as the principal uncoloured components. Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No15985Einecs220-491-7Chemical namesDisodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate Chemical formulaC16H10N2Na2O7S2Molecular weight452,37Assay Content not less than 85 % total colouring matters calculated as the sodium salt E1 cm1 % 555 at ca 485 nm in aqueous solution at pH 7 DescriptionOrange-red powder or granulesIdentification A. Spectrometry Maximum in water at ca 485 nm at pH 7 B. Orange solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot 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 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) Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgE 120 COCHINEAL, CARMINIC ACID, CARMINESDefinition

Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa. The colouring principle is carminic acid. Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2. In commercial products the colouring principle is 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, and may also contain free carminate or a small residue of unbound aluminium cations. ClassAnthraquinoneColour Index No75470EinecsCochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4 Chemical names7-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 acidChemical formulaC22H20O13 (carminic acid)Molecular weight492,39 (carminic acid)AssayContent not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.DescriptionRed to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.IdentificationSpectrometry Maximum in aqueous ammonia solution at ca 518 nm Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid PurityArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 122 AZORUBINE, CARMOISINESynonymsCI Food Red 3Definition 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 sulfate as the principal uncoloured components. Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No14720Einecs222-657-4Chemical nameDisodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonateChemical formulaC20H12N2Na2O7S2Molecular weight502,44Assay Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm1 % 510 at ca 516 nm in aqueous solution DescriptionRed to maroon powder or granulesIdentification A. Spectrometry Maximum in water at ca 516 nm B. Red solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 2,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid 4-hydroxynaphthalene-1-sulfonic acid Total not more than 0,5 % Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 123 AMARANTHSynonymsCI Food Red 9Definition

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 sulfate as the principal uncoloured components. Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No16185Einecs213-022-2Chemical nameTrisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonateChemical formulaC20H11N2Na3O10S3Molecular weight604,48Assay Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm1 % 440 at ca 520 nm in aqueous solution DescriptionReddish-brown powder or granulesIdentification A. Spectrometry Maximum in water at ca 520 nm B. Red solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 3,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kg LeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 124 PONCEAU 4R, COCHINEAL RED ASynonymsCI Food Red 7, New CoccineDefinition 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 sulfate as the principal uncoloured components. Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No16255Einecs220-036-2Chemical nameTrisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonateChemical formulaC20H11N2Na3O10S3Molecular weight604,48Assay Content not less than 80 % total colouring matters, calculated as the sodium salt. E1 cm1 % 430 at ca 505 nm in aqueous solution DescriptionReddish powder or granulesIdentification A. Spectrometry Maximum in water at ca 505 nm B. Red solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 1,0 % Organic compounds other than colouring matters: 4-aminonaphthalene-1-sulfonic acid 7-hydroxynaphthalene-1,3-disulfonic acid 3-hydroxynaphthalene-2,7-disulfonic acid 6-hydroxynaphthalene-2-sulfonic acid 7-hydroxynaphthalene-1,3-6-trisulfonic acid Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kg MercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 127 ERYTHROSINESynonymsCI Food Red 14Definition

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 sulfate as the principal uncoloured components. Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassXanthenColour Index No45430Einecs240-474-8Chemical nameDisodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrateChemical formulaC20H6I4Na2O5.H2OMolecular weight897,88Assay Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt E1 cm1 %1100 at ca 526 nm in aqueous solution at pH 7 DescriptionRed powder or granules.Identification A. Spectrometry Maximum in water at ca 526 nm at pH 7 B. Red solution in water PurityInorganic iodides calculated as sodium iodideNot more than 0,1 %Water insoluble matterNot more than 0,2 %Subsidiary colouring matters (except fluorescein)Not more than 4,0 %FluoresceinNot more than 20 mg/kgOrganic compounds other than colouring matters:Tri-iodoresorcinolNot more than 0,2 %2-(2,4-dihydroxy-3,5-diodobenzoyl) benzoic acidNot more than 0,2 %Ether extractable matterFrom a solution of pH from 7 through 8, not more than 0,2 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgAluminium LakesThe hydrochloric acid insoluble matter method is not applicable. It is replaced by a sodium hydroxide insoluble matter, at not more than 0,5 %, for this colour only. E 128 RED 2GSynonymsCI Food Red 10, AzogeranineDefinition Red 2G consists essentially of disodium 8-acetamido-1-hydroxy-2-phenylazonaphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. Red 2G is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No18050Einecs223-098-9Chemical nameDisodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonateChemical formulaC18H13N3Na2O8S2Molecular weight509,43Assay Content not less than 80 % total colouring matters, calculated as the sodium salt E1 cm1 % 620 at ca 532 nm in aqueous solution DescriptionRed powder or granulesIdentification A. Spectrometry Maximum in water at ca 532 nm B. Red solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 2,0 % Organic compounds other than colouring matters: 5-acetamido-4-hydroxynaphthalene-2,7-disulfonic acid 5-amino-4-hydroxynaphthalene-2,7-disulfonic acid Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 129 ALLURA RED ACSynonymsCI Food Red 17Definition

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 sulfate as the principal uncoloured components. Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassMonoazoColour Index No16035 Einecs247-368-0Chemical nameDisodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonateChemical formulaC18H14N2Na2O8S2Molecular weight496,42Assay Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm1 % 540 at ca 504 nm in aqueous solution at pH 7 DescriptionDark red powder or granulesIdentification A. Spectrometry Maximum in water at ca 504 nm B. Red solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 3,0 %Organic compounds other than colouring matters:6-hydroxy-2-naphthalene sulfonic acid, sodium saltNot more than 0,3 %4-amino-5-methoxy-2-methylbenezene sulfonic acidNot more than 0,2 %6,6-oxybis (2-naphthalene sulfonic acid) disodium saltNot more than 1,0 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterFrom a solution of pH 7, not more than 0,2 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 131 PATENT BLUE VSynonymsCI Food Blue 5Definition 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 sulfate and/or calcium sulfate as the principal uncoloured components. The potassium salt is also permitted. ClassTriarylmethaneColour Index No42051Einecs222-573-8Chemical namesThe calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner saltChemical formula Calcium compound: C27H31N2O7S2Ca12 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 E1 cm1 %2000 at ca 638 nm in aqueous solution at pH 5 DescriptionDark-blue powder or granulesIdentification A. Spectrometry Maximum in water at 638 nm at pH 5 B. Blue solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 2,0 % Organic compounds other than colouring matters: 3-hydroxy benzaldehyde 3-hydroxy benzoic acid 3-hydroxy-4-sulfobenzoic acid N,N-diethylamino benzene sulfonic acid Total not more than 0,5 %Leuco baseNot more than 4,0 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterFrom a solution of pH 5 not more than 0,2 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 132 INDIGOTINE, INDIGO CARMINESynonymsCI Food Blue 1Definition

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 sulfate as the principal uncoloured components. Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassIndigoidColour Index No73015Einecs212-728-8Chemical namesDisodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonateChemical formulaC16H8N2Na2O8S2Molecular weight466,36Assay 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 % E1 cm1 % 480 at ca 610 nm in aqueous solution DescriptionDark-blue powder or granulesIdentification A. Spectrometry Maximum in water at ca 610 nm B. Blue solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersExcluding 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 5-sulfoanthranilic acid Anthranilic acid Total not more than 0,5 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 133 BRILLIANT BLUE FCFSynonymsCI Food Blue 2Definition 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 sulfate as the principal uncoloured components. Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassTriarylmethaneColour Index No42090Einecs223-339-8Chemical namesDisodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonateChemical formulaC37H34N2Na2O9S3Molecular weight792,84Assay Content not less than 85 % total colouring matters, calculated as the sodium salt E1 cm1 %1630 at ca 630 nm in aqueous solution DescriptionReddish-blue powder or granulesIdentification A. Spectrometry Maximum in water at ca 630 nm B. Blue solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 6,0 % Organic compounds other than colouring matters:Sum of 2-, 3- and 4-formyl benzene sulfonic acidsNot more than 1,5 %3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acidNot more than 0,3 %Leuco baseNot more than 5,0 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % at pH 7ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 140 (i) CHLOROPHYLLSSynonymsCI Natural Green 3, Magnesium Chlorophyll, Magnesium PhaeophytinDefinitionChlorophylls are obtained by solvent extraction of natural strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated 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.ClassPorphyrinColour Index No75810EinecsChlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4Chemical names

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, (Pheophytin 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 % E1 cm1 % 700 at ca 409 nm in chloroform DescriptionWaxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated magnesiumIdentificationSpectrometryMaximum in chloroform at ca 409 nmPuritySolvent residues Acetone Methyl Ethyl ketone Methanol Ethanol Propan-2-ol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: Not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 140 (ii) CHLOROPHYLLINSSynonymsCI Natural Green 5, Sodium Chlorophyllin, Potassium ChlorophyllinDefinition The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of natural 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 neutralized 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. ClassPorphyrinColour Index No75815Einecs287-483-3Chemical names 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. E1 cm1 % 700 at ca 405 nm in aqueous solution at pH 9 E1 cm1 % 140 at ca 653 nm in aqueous solution at pH 9

DescriptionDark green to blue/black powderIdentificationSpectrometryMaximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nmPuritySolvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 141 (i) COPPER COMPLEXES OF CHLOROPHYLLSSynonymsCI Natural Green 3, Copper Chlorophyll, Copper PhaeophytinDefinitionCopper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of natural 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.ClassPorphyrinColour Index No75815EinecsCopper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5Chemical names [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 %. E1 cm1 % 540 at ca 422 nm in chloroform E1 cm1 % 300 at ca 652 nm in chloroform DescriptionWaxy solid ranging in colour from blue green to dark green depending on the source materialIdentificationSpectrometryMaximum in chloroform at ca 422 nm and at ca 652 nmPuritySolvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgCopper ionsNot more than 200 mg/kgTotal copperNot more than 8,0 % of the total copper phaeophytinsE 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINSSynonymsSodium Copper Chlorophyllin, Potassium Copper Chlorophyllin, CI Natural Green 5Definition 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 natural 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 neutralized 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. ClassPorphyrinColour Index No75815EinecsChemical names 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. E1 cm1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5 E1 cm1 % 145 at ca 630 nm in aqueous phosphate buffer at pH 7,5 DescriptionDark green to blue/black powderIdentificationSpectrometryMaximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nmPuritySolvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgCopper ionsNot more than 200 mg/kgTotal copperNot more than 8,0 % of the total copper chlorophyllinsE 142 GREEN SSynonymsCI Food Green 4, Brilliant Green BSDefinition Green S consists essentially of sodium N-[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. ClassTriarylmethaneColour Index No44090Einecs221-409-2Chemical names Sodium N-[4-[4-(dimethylamino)phenyl-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 formulaC27H25N2NaO7S2Molecular Weight576,63Assay Content not less than 80 % total colouring matters calculated as the sodium salt E1 cm1 %1720 at ca 632 nm in aqueous solution DescriptionDark blue or dark green powder or granulesIdentification A. Spectrometry Maximum in water at ca 632 nm B. Blue or green solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 1,0 %Organic compounds other than colouring matters:4,4′-bis(dimethylamino)-benzhydryl alcoholNot more than 0,1 %4,4′-bis(dimethylamino)-benzophenoneNot more than 0,1 %3-hydroxynaphthalene-2,7-disulfonic acidNot more than 0,2 %Leuco baseNot more than 5,0 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 150a PLAIN CARAMELDefinitionPlain 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 caramelization, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.Einecs232-435-9DescriptionDark brown to black liquids or solidsPurityColour bound by DEAE celluloseNot more than 50 %Colour bound by phosphoryl celluloseNot more than 50 %Colour intensity0,01-0,12Total nitrogenNot more than 0,1 %Total sulphurNot more than 0,2 %ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 25 mg/kg

E 150b CAUSTIC SULPHITE CARAMELDefinitionCaustic 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.Einecs232-435-9DescriptionDark brown to black liquids or solidsPurityColour bound by DEAE celluloseMore than 50 %Colour intensity0,05-0,13Total nitrogenNot more than 0,3 %Sulphur dioxideNot more than 0,2 %Total sulphur0,3-3,5 %Sulphur bound by DEAE celluloseMore than 40 %Absorbance ratio of colour bound by DEAE cellulose19-34 Absorbance ratio (A 280/560) Greater than 50ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 25 mg/kgE 150c AMMONIA CARAMELDefinitionAmmonia 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.Einecs232-435-9DescriptionDark brown to black liquids or solidsPurityColour bound by DEAE celluloseNot more than 50 %Colour bound by phosphoryl celluloseMore than 50 %Colour intensity0,08-0,36Ammoniacal nitrogenNot more than 0,3 %4-methylimidazoleNot more than 250 mg/kg2-acetyl-4-tetrahydroxy-butylimidazoleNot more than 10 mg/kg Total sulphurNot more than 0,2 %Total nitrogen0,7-3,3 %Absorbance ratio of colour bound by phosphoryl cellulose13-35ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 25 mg/kgE 150d SULPHITE AMMONIA CARAMELDefinitionSulphite 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).Einecs232-435-9DescriptionDark brown to black liquids or solidsPurityColour bound by DEAE celluloseMore than 50 %Colour intensity0,10-0,60Ammoniacal nitrogenNot more than 0,6 %Sulphur dioxideNot more than 0,2 %4-methylimidazoleNot more than 250 mg/kgTotal nitrogen0,3-1,7 %Total sulphur0,8-2,5 %Nitrogen/sulphur ratio of alcohol precipitate0,7-2,7Absorbance ratio of alcohol precipitate8-14Absorbance ratio (A 280/560)Not more than 50ArsenicNot more than 1 mg/kgLeadNot more than 2 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 25 mg/kgE 151 BRILLIANT BLACK BN, BLACK PNSynonymsCI Food Black 1

Definition Brilliant Black BN 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 sulfate as the principal uncoloured components. Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassBisazoColour Index No28440Einecs219-746-5Chemical namesTetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonateChemical formulaC28H17N5Na4O14S4Molecular weight867,69Assay Content not less than 80 % total colouring matters calculated as the sodium salt E1 cm1 % 530 at ca 570 nm in solution DescriptionBlack powder or granulesIdentification A. Spectrometry Maximum in water at ca 570 nm B. Black-bluish solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 10 % (expressed on the dye content) Organic compounds other than colouring matters: 4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid 4-amino-5-hydroxynaphthalene-1,7-disulfonic acid 8-aminonaphthalene-2-sulfonic acid 4,4′-diazoaminodi-(benzenesulfonic acid) Total not more than 0,8 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % under neutral conditionsArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 153 VEGETABLE CARBONSynonymsVegetable blackDefinitionVegetable carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The raw material is carbonised at high temperatures. 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 No77266Einecs215-609-9Chemical namesCarbonChemical formulaCMolecular weight12,01AssayContent not less than 95 % of carbon calculated on an anhydrous and ash-free basisDescriptionBlack powder, odourless and tastelessIdentification A. Solubility Insoluble in water and organic solvents B. Burning When heated to redness it burns slowly without a flamePurityAsh (Total)Not more than 4,0 % (ignition temperature: 625 °C)ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgPolyaromatic hydrocarbonsThe extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction apparatus shall be colourless, and the fluorescence of the extract in ultraviolet light shall not be more intense than that of a solution of 0,100 mg of quinine sulfate in 1000 ml of 0,01 M sulphuric acid.Loss on dryingNot more than 12 % (120 °C, 4 hrs)Alkali soluble matterThe filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourlessE 154 BROWN FKSynonymsCI Food Brown 1Definition

Brown FK consists essentially of a mixture of: I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) and subsidiary colouring matters together with water, sodium chloride and/or sodium sulfate as the principal uncoloured components. Brown FK is described as the sodium salt. The calcium and the potassium salt are also permitted. ClassAzo (a mixture of mono-, bis- and trisazo colours)Einecs Chemical names A mixture of: I sodium 4-(2,4-diaminophenylazo) benzenesulfonate II sodium 4-(4,6-diamino-m-tolylazo) benzenesulfonate III disodium 4,4′-(4,6-diamino-1,3-phenylenebisazo)di (benzenesulfonate) IV disodium 4,4′-(2,4-diamino-1,3-phenylenebisazo)di (benzenesulfonate) V disodium 4,4′-(2,4-diamino-5-methyl-1,3-phenylenebisazo)di (benzenesulfonate) VI trisodium 4,4′,4″-(2,4-diaminobenzene-1,3,5-trisazo)tri-(benzenesulfonate) Chemical formula I C12H11N4NaO3S II C13H13N4NaO3S III C18H14N6Na2O6S2 IV C18H14N6Na2O6S2 V C19H16N6Na2O6S2 VI C24H17N8Na3O9S3 Molecular weight I 314,30 II 328,33 III 520,46 IV 520,46 V 534,47 VI 726,59 Assay Content not less than 70 % total colouring matters Of the total colouring matters present the proportions of the components shall not exceed: I 26 % II 17 % III 17 % IV 16 % V 20 % VI 16 % DescriptionRed-brown powder or granulesIdentificationOrange to reddish solutionPurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 3,5 %Organic compounds other than colouring matters:4-aminobenzene-1-sulfonic acidNot more than 0,7 %m-phenylenediamine and 4-methyl-m-phenylenediamineNot more than 0,35 %Unsulfonated primary aromatic amines other than m-phenylene diamine and 4-methyl-m-phenylene diamineNot more than 0,007 % (calculated as aniline) Ether extractable matterFrom a solution of pH 7, not more than 0,2 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 155 BROWN HTSynonymsCI Food Brown 3Definition 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 sulfate as the principal uncoloured components. Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted. ClassBisazoColour Index No20285Einecs224-924-0Chemical namesDisodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)Chemical formulaC27H18N4Na2O9S2Molecular Weight652,57Assay Content not less than 70 % total colouring matters calculated as the sodium salt. E1 cm1 % 403 at ca 460 nm in aqueous solution at pH 7

DescriptionReddish-brown powder or granulesIdentification A. Spectrometry Maximum in water of pH 7 at ca 460 nm B. Brown solution in water PurityWater insoluble matterNot more than 0,2 %Subsidiary colouring mattersNot more than 10 % (TLC method)Organic compounds other than colouring matters:4-aminonaphthalene-1-sulfonic acidNot more than 0,7 %Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)Ether extractable matterNot more than 0,2 % in a solution of pH 7ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 160a (i) MIXED CAROTENES

1. Plant carotenes SynonymsCI Food Orange 5 Definition Mixed carotenes are obtained by solvent extraction of natural 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, dichloromethane and carbon dioxide. ClassCarotenoidColour Index No75130Einecs230-636-6Chemical formulaBeta-carotene: C40H56Molecular weightBeta-carotene: 536,88Assay 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. E1 cm1 %2500 at approximately 440 nm to 457 nm in cyclohexane IdentificationSpectrometryMaximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nmPuritySolvent residues Acetone Methyl ethyl ketone Methanol Propan-2-ol Hexane Ethanol Not more than 50 mg/kg, singly or in combinationDichloromethane: Not more than 10 mg/kgLeadNot more than 5 mg/kg
2. Algal carotenes SynonymsCI Food Orange 5Definition Mixed carotenes may also be produced from natural strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. 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. ClassCarotenoidColour Index No75130Chemical formulaBeta-Carotene: C40H56Molecular weightBeta-Carotene: 536,88Assay Content of carotenes (calculated as beta-carotene) is not less than 20 % E1 cm1 %2500 at approximately by 440 nm to 457 nm in cyclohexane IdentificationSpectrometryMaximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm PurityNatural tocopherols in edible oilNot more than 0,3 %LeadNot more than 5 mg/kgE 160a (ii) BETA-CAROTENE

1. Beta-carotene SynonymsCI Food Orange 5DefinitionThese 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.ClassCarotenoidColour Index No40800Einecs230-636-6Chemical namesBeta-carotene, beta, beta-caroteneChemical formulaC40H56Molecular weight536,88Assay Not less than 96 % total colouring matters (expressed as beta-carotene) E1 cm1 %2500 at approximately by 440 nm to 457 nm in cyclohexane DescriptionRed to brownish-red crystals or crystalline powderIdentificationSpectrometryMaximum in cyclohexane at 453 nm to 456 nmPuritySulfated ashNot more than 0,2 %Subsidiary colouring mattersCarotenoids other than beta-carotene: not more than 3,0 % of total colouring mattersLeadNot more than 2 mg/kg
2. Beta-carotene from Blakeslea trispora SynonymsCI Food Orange 5DefinitionObtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of natural strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate, or isobutyl acetate followed by isopropyl alcohol, 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.ClassCarotenoidColour Index No40800Einecs230-636-6Chemical namesBeta-carotene, beta,beta-caroteneChemical formulaC40H56Molecular weight536,88Assay Not less than 96 % total colouring matters (expressed as beta-carotene) E1 cm1 %2500 at approximately 440 nm to 457 nm in cyclohexane DescriptionRed, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)IdentificationSpectrometryMaximum in cyclohexane at 453 nm to 456 nm PuritySolvent residues Ethyl acetate Ethanol Not more than 0,8 %, singly or in combinationIsobutyl acetate: Not more than 1,0 %Isopropyl alcohol: Not more than 0,1 %Sulfated ashNot more than 0,2 %Subsidiary colouring mattersCarotenoids other than beta-carotene: not more than 3,0 % of total colouring mattersLeadNot more than 2 mg/kgMycotoxins:Aflatoxin B1AbsentTrichothecene (T2)AbsentOchratoxinAbsentZearalenoneAbsentMicrobiology:MouldsNot more than 100/gYeastsNot more than 100/gSalmonellaAbsent in 25 gEscherichia coliAbsent in 5 gE 160b ANNATTO, BIXIN, NORBIXINSynonymsCI Natural Orange 4DefinitionClassCarotenoidColour Index No75120EinecsAnnatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7Chemical namesBixin 6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate 6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate Norbixin 9′Cis-6,6′-diapocarotene-6,6′-dioic acid 9′-Trans-6,6′-diapocarotene-6,6′-dioic acid Chemical formulaBixinC25H30O4NorbixinC24H28O4Molecular weightBixin394,51Norbixin380,48DescriptionReddish-brown powder, suspension or solutionIdentificationSpectrometryBixinmaximum in chloroform at ca 502 nmNorbixinmaximum in dilute KOH solution at ca 482 nm

(i) Solvent extracted bixin and norbixin Definition Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent. Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin. Bixin and norbixin may contain other materials extracted from the annatto seed. The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present. The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present. Assay Content of bixin powders not less than 75 % total carotenoids calculated as bixin. Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin BixinE1 cm1 %2870 at ca 502 nm in chloroformNorbixinE1 cm1 %2870 at ca 482 nm in KOH solutionPuritySolvent residues Acetone Methanol Hexane not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kg (ii) Alkali extracted annatto Definition Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.) Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present. Assay Contains not less than 0,1 % of total carotenoids expressed as norbixin NorbixinE1 cm1 %2870 at ca 482 nm in KOH solutionPurityArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kg (iii) Oil extracted annatto DefinitionAnnatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and transforms. Thermal degradation products of bixin may also be present.Assay Contains not less than 0,1 % of total carotenoids expressed as bixin BixinE1 cm1 %2870 at ca 502 nm in chloroformPurityArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBINSynonymsPaprika OleoresinDefinition Paprika extract is obtained by solvent extraction of the natural 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 and carbon dioxide. ClassCarotenoidEinecsCapsanthin: 207-364-1, capsorubin: 207-425-2Chemical names Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,k-carotene-6-one Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-k,k-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 E1 cm1 %2100 at ca 462 nm in acetone DescriptionDark-red viscous liquidIdentification A. Spectrometry Maximum in acetone at ca 462 nm B. Colour reaction A deep blue colour is produced by adding one drop of sulfuric acid to one drop of sample in 2-3 drops of chloroformPuritySolvent residues Ethyl acetate Methanol Ethanol Acetone Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kg CapsaicinNot more than 250 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 160d LYCOPENESynonymsNatural Yellow 27DefinitionLycopene is obtained by solvent extraction of the natural strains of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvents may be used: dichloromethane, carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol, hexane. The major colouring principle of tomatoes is lycopene, minor amounts of other carotenoid pigments may be present. Beside the other colour pigments the product may contain oils, fats, waxes, and flavour components naturally occurring in tomatoes.ClassCarotenoidColour Index No75125Chemical namesLycopene, ψ,ψ-caroteneChemical formulaC40H56Molecular weight536,85Assay Content not less than 5 % total colouring matters E1 cm1 %3450 at ca 472 nm in hexane DescriptionDark red viscous liquidIdentificationSpectrometryMaximum in hexane at ca 472 nmPuritySolvent residues Ethyl acetate Methanol Ethanol Acetone Hexane Propan-2-ol Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgSulfated ashNot more than 0,1 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 160e BETA-APO-8′-CAROTENAL (C30)SynonymsCI Food Orange 6 DefinitionThese specifications apply to predominantly all trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized 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.ClassCarotinoidColour Index No40820Einecs214-171-6Chemical namesβ-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehydeChemical formulaC30H40OMolecular weight416,65Assay

Not less than 96 % of total colouring matters E1 cm1 %2640 at ca 460-462 nm in cyclohexane DescriptionDark violet crystals with metallic lustre or crystalline powderIdentificationSpectrometryMaximum in cyclohexane at 460-462 nmPuritySulfated ashNot more than 0,1 %Subsidiary colouring matters Carotenoids other than β-apo-8′-carotenal: not more than 3,0 % of total colouring matters ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)SynonymsCI Food Orange 7, β-apo-8′-carotenoic esterDefinitionThese specifications apply to predominantly all trans isomer of β-apo-8′-carotenoic acid ethyl ester together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenoic acid ethyl ester meeting these specifications and include solutions or suspensions of β-apo-8′-carotenoic acid ethyl ester in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.ClassCarotenoidColour Index No40825Einecs214-173-7Chemical namesβ-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oateChemical formulaC32H44O2Molecular weight460,70Assay Not less than 96 % of total colouring matters E1 cm1 %2550 at ca 449 nm in cyclohexane DescriptionRed to violet-red crystals or crystalline powderIdentificationSpectrometryMaximum in cyclohexane at ca 449 nm PuritySulfated ashNot more than 0,1 %Subsidiary colouring mattersCarotenoids other than β-apo-8′-carotenoic acid ethyl ester: not more than 3,0 % of total colouring mattersArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 161b LUTEINSynonymsMixed Carotenoids, XanthophyllsDefinition Lutein is obtained by solvent extraction of the natural 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, dichloromethane and carbon dioxide ClassCarotenoidEinecs204-840-0Chemical names3,3′-dihydroxy-d-caroteneChemical formulaC40H56O2Molecular weight568,88Assay Content of total colouring matter not less than 4 % calculated as lutein E1 cm1 %2550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10) DescriptionDark, yellowish brown liquidIdentificationSpectrometryMaximum in chloroform/ethanol (10 + 90) at ca 445 nmPuritySolvent residues Acetone Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane Not more than 50 mg/kg, singly or in combinationDichloromethane: not more than 10 mg/kgArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kg

E 161g CANTHAXANTHINSynonymsCI Food Orange 8DefinitionThese specifications apply to predominantly all trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized 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.ClassCarotinoidColour Index No40850Einecs208-187-2Chemical namesβ-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-caroteneChemical formulaC40H52O2Molecular weight564,86Assay Not less than 96 % of total colouring matters (expressed as canthaxanthin) E1 cm1 %2200 at ca 485 nm in chloroform at 468-472 nm in cyclohexane at 464-467 nm in petroleum ether DescriptionDeep violet crystals or crystalline powderIdentificationSpectrometry Maximum in chloroform at ca 485 nm Maximum in cyclohexane at 468-472 nm Maximum in petroleum ether at 464-467 nm PuritySulfated ashNot more than 0,1 %Subsidiary colouring mattersCarotenoids other than canthaxanthin: not more than 5,0 % of total colouring mattersArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 162 BEETROOT RED, BETANINSynonymsBeet RedDefinition Beet red is obtained from the roots of natural 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. ClassBetalaine Einecs231-628-5Chemical names(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-carboxylateChemical formulaBetanin: C24H26N2O13Molecular weight550,48Assay Content of red colour (expressed as betanine) is not less than 0,4 % E1 cm1 %1120 at ca 535 nm in aqueous solution at pH 5 DescriptionRed or dark red liquid, paste, powder or solidIdentificationSpectrometryMaximum in water of pH 5 at ca 535 nmPurityNitrateNot more than 2 g nitrate anion/g of red colour (as calculated from assay).ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 163 ANTHOCYANINSDefinitionAnthocyanins are obtained by extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the natural strains of vegetables and edible fruits. 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.ClassAnthocyaninEinecs208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin)Chemical names

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 AssayE1 cm1 % 300 for the pure pigment at 515-535 nm at pH 3,0DescriptionPurplish-red liquid, powder or paste, having a slight characteristic odourIdentificationSpectrometry 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 PuritySolvent residues Methanol Ethanol Not more than 50 mg/kg, singly or in combinationSulfur dioxideNot more than 1000 mg/kg per percent pigmentArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 170 CALCIUM CARBONATESynonymsCI Pigment White 18, ChalkDefinitionCalcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.ClassInorganicColour Index No77220Einecs Calcium carbonate: 207-439-9 Limestone: 215-279-6 Chemical namesCalcium carbonateChemical formulaCaCO3Molecular weight100,1AssayContent not less than 98 % on the anhydrous basisDescriptionWhite crystalline or amorphous, odourless and tasteless powderIdentificationSolubilityPractically 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. PurityLoss on dryingNot more than 2,0 % (200 °C, 4 hours)Acid-insoluble substancesNot more than 0,2 %Magnesium and alkali saltsNot more than 1,5 %FluorideNot more than 50 mg/kg Antimony (as Sb) Copper (as Cu) Chromium (as Cr) Zinc (as Zn) Barium (as Ba) Not more than 100 mg/kg, singly or in combinationArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgCadmiumNot more than 1 mg/kgE 171 TITANIUM DIOXIDESynonymsCI Pigment White 6DefinitionTitanium 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.ClassInorganicColour Index No77891Einecs236-675-5Chemical namesTitanium dioxideChemical formulaTiO2Molecular weight79,88AssayContent not less than 99 % on an alumina and silica-free basisDescriptionWhite to slightly coloured powderIdentificationSolubilityInsoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.PurityLoss on dryingNot more than 0,5 % (105 °C, 3 hours)Loss on ignitionNot more than 1,0 % on a volatile matter free basis (800 °C)Aluminium oxide and/or silicon dioxideTotal not more than 2,0 %Matter soluble in 0,5 N HClNot 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 matterNot more than 0,5 %CadmiumNot more than 1 mg/kgAntimonyNot more than 50 mg/kg by total dissolutionArsenicNot more than 3 mg/kg by total dissolutionLeadNot more than 10 mg/kg by total dissolutionMercuryNot more than 1 mg/kg by total dissolutionZinkNot more than 50 mg/kg by total dissolution

E 172 IRON OXIDES AND IRON HYDROXIDESSynonymsIron Oxide YellowCI Pigment Yellow 42 and 43Iron Oxide RedCI Pigment Red 101 and 102Iron Oxide BlackCI Pigment Black 11DefinitionIron 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.ClassInorganicColour Index NoIron Oxide Yellow77492Iron Oxide Red77491Iron Oxide Black77499EinecsIron Oxide Yellow257-098-5Iron Oxide Red215-168-2Iron Oxide Black235-442-5Chemical namesIron Oxide Yellowhydrated ferric oxide, hydrated iron (III) oxideIron Oxide Redanhydrous ferric oxide, anhydrous iron (III) oxideIron Oxide Blackferroso ferric oxide, iron (II, III) oxideChemical formulaIron Oxide YellowFeO(OH)·H2OIron Oxide RedFe2O3Iron Oxide BlackFeO·Fe2O3Molecular weight88,85FeO(OH)159,70Fe2O3231,55FeO·Fe2O3AssayYellow not less than 60 %, red and black not less than 68 % total iron, expressed as ironDescriptionPowder; yellow, red, brown or black in hueIdentificationSolubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids PurityWater soluble matterNot more than 1,0 %By total dissolutionArsenicNot more than 5 mg/kgBariumNot more than 50 mg/kgCadmiumNot more than 5 mg/kgChromiumNot more than 100 mg/kgCopperNot more than 50 mg/kgLeadNot more than 20 mg/kgMercuryNot more than 1 mg/kgNickelNot more than 200 mg/kgZincNot more than 100 mg/kg E 173 ALUMINIUMSynonymsCI Pigment Metal, AlDefinitionAluminium 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 No77000Einecs231-072-3Chemical namesAluminiumChemical formulaAlAtomic weight26,98AssayNot less than 99 % calculated as Al on an oil-free basisDescriptionA silvery-grey powder or tiny sheetsIdentificationSolubilityInsoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.PurityLoss on dryingNot more than 0,5 % (105 °C, to constant weight)ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kgE 174 SILVERSynonymsArgentum, AgClassInorganicColour Index No77820Einecs231-131-3Chemical namesSilverChemical formulaAgAtomic weight107,87AssayContent not less than 99,5 % AgDescriptionSilver-coloured powder or tiny sheetsE 175 GOLDSynonymsPigment Metal 3, Aurum, AuClassInorganicColour Index No77480Einecs231-165-9Chemical namesGoldChemical formulaAuAtomic weight197,0AssayContent not less than 90 % Au

DescriptionGold-coloured powder or tiny sheetsPuritySilverNot more than 7,0 %After complete dissolutionCopperNot more than 4,0 %E 180 LITHOLRUBINE BKSynonymsCI Pigment Red 57, Rubinpigment, Carmine 6BDefinitionLithol 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 sulfate as the principal uncoloured components.ClassMonoazoColour Index No15850:1Einecs226-109-5Chemical namesCalcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylateChemical formulaC18H12CaN2O6SMolecular weight424,45Assay Content not less than 90 % total colouring matters E1 cm1 % 200 at ca 442 nm in dimethylformamide DescriptionRed powderIdentificationSpectrometryMaximum in dimethylformamide at ca 442 nmPuritySubsidiary colouring mattersNot more than 0,5 %Organic compounds other than colouring matters:2-Amino-5-methylbenzenesulfonic acid, calcium saltNot more than 0,2 %3-hydroxy-2-naphthalenecarboxylic acid, calcium saltNot more than 0,4 %Unsulfonated primary aromatic aminesNot more than 0,01 % (expressed as aniline)Ether extractable matterFrom a solution of pH 7, not more than 0,2 %ArsenicNot more than 3 mg/kgLeadNot more than 10 mg/kgMercuryNot more than 1 mg/kgCadmiumNot more than 1 mg/kgHeavy metals (as Pb)Not more than 40 mg/kg

Annex

ANNEX II PART A Repealed Directive with list of its successive amendments (referred to in Article 2) Commission Directive 95/45/EC(OJ L 226, 22.9.1995, p. 1)Commission Directive 1999/75/EC(OJ L 206, 5.8.1999, p. 19)Commission Directive 2001/50/EC(OJ L 190, 12.7.2001, p. 14)Commission Directive 2004/47/EC(OJ L 113, 20.4.2004, p. 24)Commission Directive 2006/33/EC(OJ L 82, 21.3.2006, p. 10) PART B List of time-limits for transposition into national law (referred to in Article 2) According to Article 2(2) of Directive 95/45/EC, products put on the market or labelled before 1 July 1996 which do not comply with that Directive may, however, be marketed until stocks are exhausted. According to Article 3 of Directive 2004/47/EC, products on the market or labelled before 1 April 2005 which do not comply with that Directive may be marketed until stocks are exhausted. DirectiveTime-limit for transposition95/45/EC1 July 19961999/75/EC1 July 20002001/50/EC29 June 20022004/47/EC1 April 20052006/33/EC10 April 2007

Annex

ANNEX III Correlation table Directive 95/45/ECThis DirectiveArticle 1, first paragraphArticle 1Article 1, second paragraph—Article 2——Article 2Article 3Article 3Article 4Article 4AnnexAnnex I—Annex II—Annex III