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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(Text with EEA relevance) (repealed)

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(1), 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(2) has been substantially amended several times(3). 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(4).

(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 1U.K.

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 2U.K.

Directive 95/45/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex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References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.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 3U.K.

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

Article 4U.K.

This Directive is addressed to the Member States.

ANNEX IU.K.

A.GENERAL SPECIFICATIONS FOR ALUMINIUM LAKES OF COLOURSU.K.

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 PURITYU.K.

a

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.

b

Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

c

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).

d

Benzene not more than 0,05 % v/v.

E 100 CURCUMIN
SynonymsCI Natural Yellow 3, Turmeric Yellow, Diferoyl Methane
Definition

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.

ClassDicinnamoylmethane
Colour Index No75300
Einecs207-280-5
Chemical names
I1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
II1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione
III1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
Chemical formula
IC21H20O6
IIC20H18O5
IIIC19H16O4
Molecular weight
I.

368,39

II.

338,39

III.

308,39

Assay

Content not less than 90 % total colouring matters

E1 cm 1 %1 607 at ca 426 nm in ethanol

DescriptionOrange-yellow crystalline powder
Identification
A.Spectrometry
Maximum in ethanol at ca 426 nm
B.Melting Range
179 °C-182 °C
Purity
Solvent residues

Ethylacetate

Acetone

n-butanol

Methanol

Ethanol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 101 (i) RIBOFLAVIN
SynonymsLactoflavin
ClassIsoalloxazine
Einecs201-507-1
Chemical 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 formulaC17H20N4O6
Molecular weight376,37
Assay

Content not less than 98 % on the anhydrous basis

E1 cm 1 % 328 at ca 444 nm in aqueous solution

DescriptionYellow to orange-yellow crystalline powder, with slight odour
Identification
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 solution
Maximum in water at ca 444 nm
B.Specific rotation
[α]D20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution
Purity
Loss on dryingNot more than 1,5 % after drying at 105 °C for 4 hrs
Sulfated ashNot more than 0,1 %
Primary aromatic aminesNot more than 100 mg/kg (calculated as aniline)
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
SynonymsRiboflavin-5′-phosphate sodium
DefinitionThese specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate
ClassIsoalloxazine
Einecs204-988-6
Chemical 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 formula
For the dihydrate form

:

C17H20N4NaO9P·2H2O

For the anhydrous form

:

C17H20N4NaO9P

Molecular weight541,36
Assay

Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P·2H2O

E1 cm 1 % 250 at ca 375 nm in aqueous solution

DescriptionYellow to orange crystalline hygroscopic powder, with slight odour and a bitter taste
Identification
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 solution
Maximum in water at ca 444 nm
B.Specific rotation
[α]D20 between + 38° and + 42° in a 5 molar HCl solution
Purity
Loss on dryingNot more than 8 % (100 °C, 5 hrs in vacuum over P2O5) for the dihydrate form
Sulfated ashNot more than 25 %
Inorganic phosphateNot 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 aminesNot more than 70 mg/kg (calculated as aniline)
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 102 TARTRAZINE
SynonymsCI Food Yellow 4
Definition

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.

ClassMonoazo
Colour Index No19140
Einecs217-699-5
Chemical namesTrisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate
Chemical formulaC16H9N4Na3O9S2
Molecular weight534,37
Assay

Content not less than 85 % total colouring matters calculated as the sodium salt

E1 cm 1 % 530 at ca 426 nm in aqueous solution

DescriptionLight orange powder or granules
Identification
A.Spectrometry
Maximum in water at ca 426 nm
B.Yellow solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 104 QUINOLINE YELLOW
SynonymsCI Food Yellow 13
Definition

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.

ClassChinophthalone
Colour Index No47005
Einecs305-897-5
Chemical 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 cm 1 % 865 (principal component) at ca 411 nm in aqueous acetic acid solution

DescriptionYellow powder or granules
Identification
A.Spectrometry
Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm
B.Yellow solution in water
Purity
Water 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/kg
Unsulfonated primary aromatic aminesNot more than 0,01 % (calculated as aniline)
Ether extractable matterNot more than 0,2 % under neutral conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 110 SUNSET YELLOW FCF
SynonymsCI 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 sulfate as the principal uncoloured components.

Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassMonoazo
Colour Index No15985
Einecs220-491-7
Chemical namesDisodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate
Chemical formulaC16H10N2Na2O7S2
Molecular weight452,37
Assay

Content not less than 85 % total colouring matters calculated as the sodium salt

E1 cm 1 % 555 at ca 485 nm in aqueous solution at pH 7

DescriptionOrange-red powder or granules
Identification
A.Spectrometry
Maximum in water at ca 485 nm at pH 7
B.Orange solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
E 120 COCHINEAL, CARMINIC ACID, CARMINES
Definition

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.

ClassAnthraquinone
Colour Index No75470
EinecsCochineal: 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 acid
Chemical 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.
Identification
Spectrometry

Maximum in aqueous ammonia solution at ca 518 nm

Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid

Purity
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 122 AZORUBINE, CARMOISINE
SynonymsCI 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 sulfate as the principal uncoloured components.

Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassMonoazo
Colour Index No14720
Einecs222-657-4
Chemical nameDisodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
Chemical formulaC20H12N2Na2O7S2
Molecular weight502,44
Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 510 at ca 516 nm in aqueous solution

DescriptionRed to maroon powder or granules
Identification
A.Spectrometry
Maximum in water at ca 516 nm
B.Red solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 123 AMARANTH
SynonymsCI 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 sulfate as the principal uncoloured components.

Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassMonoazo
Colour Index No16185
Einecs213-022-2
Chemical nameTrisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate
Chemical formulaC20H11N2Na3O10S3
Molecular weight604,48
Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 440 at ca 520 nm in aqueous solution

DescriptionReddish-brown powder or granules
Identification
A.Spectrometry
Maximum in water at ca 520 nm
B.Red solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 124 PONCEAU 4R, COCHINEAL RED A
SynonymsCI 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 sulfate as the principal uncoloured components.

Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassMonoazo
Colour Index No16255
Einecs220-036-2
Chemical nameTrisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate
Chemical formulaC20H11N2Na3O10S3
Molecular weight604,48
Assay

Content not less than 80 % total colouring matters, calculated as the sodium salt.

E1 cm 1 % 430 at ca 505 nm in aqueous solution

DescriptionReddish powder or granules
Identification
A.Spectrometry
Maximum in water at ca 505 nm
B.Red solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 127 ERYTHROSINE
SynonymsCI 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 sulfate as the principal uncoloured components.

Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassXanthen
Colour Index No45430
Einecs240-474-8
Chemical nameDisodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate
Chemical formulaC20H6I4Na2O5.H2O
Molecular weight897,88
Assay

Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt

E1 cm 1 %1 100 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
Purity
Inorganic 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/kg
Organic 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
Aluminium 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 2G
SynonymsCI Food Red 10, Azogeranine
Definition

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.

ClassMonoazo
Colour Index No18050
Einecs223-098-9
Chemical nameDisodium 8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate
Chemical formulaC18H13N3Na2O8S2
Molecular weight509,43
Assay

Content not less than 80 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 620 at ca 532 nm in aqueous solution

DescriptionRed powder or granules
Identification
A.Spectrometry
Maximum in water at ca 532 nm
B.Red solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 129 ALLURA RED AC
SynonymsCI 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 sulfate as the principal uncoloured components.

Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassMonoazo
Colour Index No16035
Einecs247-368-0
Chemical nameDisodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate
Chemical formulaC18H14N2Na2O8S2
Molecular weight496,42
Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 % 540 at ca 504 nm in aqueous solution at pH 7

DescriptionDark red powder or granules
Identification
A.Spectrometry
Maximum in water at ca 504 nm
B.Red solution in water
Purity
Water 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 131 PATENT BLUE V
SynonymsCI 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 sulfate and/or calcium sulfate as the principal uncoloured components.

The potassium salt is also permitted.

ClassTriarylmethane
Colour Index No42051
Einecs222-573-8
Chemical 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 salt
Chemical formula

Calcium compound: C27H31N2O7S2Ca

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 cm 1 %2 000 at ca 638 nm in aqueous solution at pH 5

DescriptionDark-blue powder or granules
Identification
A.Spectrometry
Maximum in water at 638 nm at pH 5
B.Blue solution in water
Purity
Water 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 132 INDIGOTINE, INDIGO CARMINE
SynonymsCI 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 sulfate as the principal uncoloured components.

Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassIndigoid
Colour Index No73015
Einecs212-728-8
Chemical namesDisodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate
Chemical formulaC16H8N2Na2O8S2
Molecular weight466,36
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 %

E1 cm 1 % 480 at ca 610 nm in aqueous solution

DescriptionDark-blue powder or granules
Identification
A.Spectrometry
Maximum in water at ca 610 nm
B.Blue solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 133 BRILLIANT BLUE FCF
SynonymsCI 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 sulfate as the principal uncoloured components.

Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

ClassTriarylmethane
Colour Index No42090
Einecs223-339-8
Chemical namesDisodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate
Chemical formulaC37H34N2Na2O9S3
Molecular weight792,84
Assay

Content not less than 85 % total colouring matters, calculated as the sodium salt

E1 cm 1 %1 630 at ca 630 nm in aqueous solution

DescriptionReddish-blue powder or granules
Identification
A.Spectrometry
Maximum in water at ca 630 nm
B.Blue solution in water
Purity
Water 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 7
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 140 (i) CHLOROPHYLLS
SynonymsCI Natural Green 3, Magnesium Chlorophyll, Magnesium Phaeophytin
DefinitionChlorophylls 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.
ClassPorphyrin
Colour Index No75810
EinecsChlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
Chemical names

The major colouring principles are:

  • Phytyl (132 R,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 (132 R,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 cm 1 % 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 magnesium
Identification
SpectrometryMaximum in chloroform at ca 409 nm
Purity
Solvent residues

Acetone

Methyl Ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 140 (ii) CHLOROPHYLLINS
SynonymsCI Natural Green 5, Sodium Chlorophyllin, Potassium Chlorophyllin
Definition

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.

ClassPorphyrin
Colour Index No75815
Einecs287-483-3
Chemical 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 cm 1 % 700 at ca 405 nm in aqueous solution at pH 9

E1 cm 1 % 140 at ca 653 nm in aqueous solution at pH 9

DescriptionDark green to blue/black powder
Identification
SpectrometryMaximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm
Purity
Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS
SynonymsCI Natural Green 3, Copper Chlorophyll, Copper Phaeophytin
DefinitionCopper 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.
ClassPorphyrin
Colour Index No75815
EinecsCopper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical names

[Phytyl (132 R,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 (132 R,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 cm 1 % 540 at ca 422 nm in chloroform

E1 cm 1 % 300 at ca 652 nm in chloroform

DescriptionWaxy solid ranging in colour from blue green to dark green depending on the source material
Identification
SpectrometryMaximum in chloroform at ca 422 nm and at ca 652 nm
Purity
Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Copper ionsNot more than 200 mg/kg
Total copperNot more than 8,0 % of the total copper phaeophytins
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS
SynonymsSodium 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 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.

ClassPorphyrin
Colour Index No75815
Einecs
Chemical 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 cm 1 % 565 at ca 405 nm in aqueous phosphate buffer at pH 7,5

E1 cm 1 % 145 at ca 630 nm in aqueous phosphate buffer at pH 7,5

DescriptionDark green to blue/black powder
Identification
SpectrometryMaximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at ca 630 nm
Purity
Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Copper ionsNot more than 200 mg/kg
Total copperNot more than 8,0 % of the total copper chlorophyllins
E 142 GREEN S
SynonymsCI Food Green 4, Brilliant Green BS
Definition

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.

ClassTriarylmethane
Colour Index No44090
Einecs221-409-2
Chemical names

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 formulaC27H25N2NaO7S2
Molecular Weight576,63
Assay

Content not less than 80 % total colouring matters calculated as the sodium salt

E1 cm 1 %1 720 at ca 632 nm in aqueous solution

DescriptionDark blue or dark green powder or granules
Identification
A.Spectrometry
Maximum in water at ca 632 nm
B.Blue or green solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 150a PLAIN CARAMEL
DefinitionPlain 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.
Einecs232-435-9
DescriptionDark brown to black liquids or solids
Purity
Colour bound by DEAE celluloseNot more than 50 %
Colour bound by phosphoryl celluloseNot more than 50 %
Colour intensitya0,01-0,12
Total nitrogenNot more than 0,1 %
Total sulphurNot more than 0,2 %
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 25 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL
DefinitionCaustic 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.
Einecs232-435-9
DescriptionDark brown to black liquids or solids
Purity
Colour bound by DEAE celluloseMore than 50 %
Colour intensitya0,05-0,13
Total nitrogenNot more than 0,3 %b
Sulphur dioxideNot more than 0,2 %b
Total sulphur0,3-3,5 %b
Sulphur bound by DEAE celluloseMore than 40 %
Absorbance ratio of colour bound by DEAE cellulose19-34

Absorbance ratio

(A 280/560)

Greater than 50
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 25 mg/kg
E 150c AMMONIA CARAMEL
DefinitionAmmonia 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.
Einecs232-435-9
DescriptionDark brown to black liquids or solids
Purity
Colour bound by DEAE celluloseNot more than 50 %
Colour bound by phosphoryl celluloseMore than 50 %
Colour intensitya0,08-0,36
Ammoniacal nitrogenNot more than 0,3 %b
4-methylimidazoleNot more than 250 mg/kgb
2-acetyl-4-tetrahydroxy-butylimidazoleNot more than 10 mg/kgb
Total sulphurNot more than 0,2 %b
Total nitrogen0,7-3,3 %b
Absorbance ratio of colour bound by phosphoryl cellulose13-35
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 25 mg/kg
E 150d SULPHITE AMMONIA CARAMEL
DefinitionSulphite 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).
Einecs232-435-9
DescriptionDark brown to black liquids or solids
Purity
Colour bound by DEAE celluloseMore than 50 %
Colour intensitya0,10-0,60
Ammoniacal nitrogenNot more than 0,6 %b
Sulphur dioxideNot more than 0,2 %b
4-methylimidazoleNot more than 250 mg/kgb
Total nitrogen0,3-1,7 %b
Total sulphur0,8-2,5 %b
Nitrogen/sulphur ratio of alcohol precipitate0,7-2,7
Absorbance ratio of alcohol precipitatec8-14
Absorbance ratio (A 280/560)Not more than 50
ArsenicNot more than 1 mg/kg
LeadNot more than 2 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 25 mg/kg
E 151 BRILLIANT BLACK BN, BLACK PN
SynonymsCI 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.

ClassBisazo
Colour Index No28440
Einecs219-746-5
Chemical namesTetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate
Chemical formulaC28H17N5Na4O14S4
Molecular weight867,69
Assay

Content not less than 80 % total colouring matters calculated as the sodium salt

E1 cm 1 % 530 at ca 570 nm in solution

DescriptionBlack powder or granules
Identification
A.Spectrometry
Maximum in water at ca 570 nm
B.Black-bluish solution in water
Purity
Water 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 conditions
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 153 VEGETABLE CARBON
SynonymsVegetable black
DefinitionVegetable 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 No77266
Einecs215-609-9
Chemical namesCarbon
Chemical formulaC
Molecular weight12,01
AssayContent not less than 95 % of carbon calculated on an anhydrous and ash-free basis
DescriptionBlack powder, odourless and tasteless
Identification
A.Solubility
Insoluble in water and organic solvents
B.Burning
When heated to redness it burns slowly without a flame
Purity
Ash (Total)Not more than 4,0 % (ignition temperature: 625 °C)
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
Polyaromatic 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 1 000 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 colourless
E 154 BROWN FK
SynonymsCI Food Brown 1
Definition

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 granules
Identification
Orange to reddish solution
Purity
Water 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 155 BROWN HT
SynonymsCI 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 sulfate as the principal uncoloured components.

Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.

ClassBisazo
Colour Index No20285
Einecs224-924-0
Chemical namesDisodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)
Chemical formulaC27H18N4Na2O9S2
Molecular Weight652,57
Assay

Content not less than 70 % total colouring matters calculated as the sodium salt.

E1 cm 1 % 403 at ca 460 nm in aqueous solution at pH 7

DescriptionReddish-brown powder or granules
Identification
A.Spectrometry
Maximum in water of pH 7 at ca 460 nm
B.Brown solution in water
Purity
Water 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 7
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 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, hexaned, dichloromethane and carbon dioxide.

ClassCarotenoid
Colour Index No75130
Einecs230-636-6
Chemical formulaBeta-carotene: C40H56
Molecular weightBeta-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.

E1 cm 1 %2 500 at approximately 440 nm to 457 nm in cyclohexane

Identification
SpectrometryMaximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
Purity
Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Propan-2-ol

Hexane

Ethanol

Not more than 50 mg/kg, singly or in combination
Dichloromethane: Not more than 10 mg/kg
LeadNot more than 5 mg/kg
2. Algal carotenes
SynonymsCI Food Orange 5
Definition

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.

ClassCarotenoid
Colour Index No75130
Chemical formulaBeta-Carotene: C40H56
Molecular weightBeta-Carotene: 536,88
Assay

Content of carotenes (calculated as beta-carotene) is not less than 20 %

E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

Identification
SpectrometryMaximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm
Purity
Natural tocopherols in edible oilNot more than 0,3 %
LeadNot more than 5 mg/kg
E 160a (ii) BETA-CAROTENE
1. Beta-carotene
SynonymsCI Food Orange 5
DefinitionThese 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.
ClassCarotenoid
Colour Index No40800
Einecs230-636-6
Chemical namesBeta-carotene, beta, beta-carotene
Chemical formulaC40H56
Molecular weight536,88
Assay

Not less than 96 % total colouring matters (expressed as beta-carotene)

E1 cm 1 %2 500 at approximately by 440 nm to 457 nm in cyclohexane

DescriptionRed to brownish-red crystals or crystalline powder
Identification
SpectrometryMaximum in cyclohexane at 453 nm to 456 nm
Purity
Sulfated ashNot more than 0,2 %
Subsidiary colouring mattersCarotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
LeadNot more than 2 mg/kg
2. Beta-carotene from Blakeslea trispora
SynonymsCI Food Orange 5
DefinitionObtained 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.
ClassCarotenoid
Colour Index No40800
Einecs230-636-6
Chemical namesBeta-carotene, beta,beta-carotene
Chemical formulaC40H56
Molecular weight536,88
Assay

Not less than 96 % total colouring matters (expressed as beta-carotene)

E1 cm 1 %2 500 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)
Identification
SpectrometryMaximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues

Ethyl acetate

Ethanol

Not more than 0,8 %, singly or in combination
Isobutyl 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 matters
LeadNot more than 2 mg/kg
Mycotoxins:
Aflatoxin B1Absent
Trichothecene (T2)Absent
OchratoxinAbsent
ZearalenoneAbsent
Microbiology:
MouldsNot more than 100/g
YeastsNot more than 100/g
SalmonellaAbsent in 25 g
Escherichia coliAbsent in 5 g
E 160b ANNATTO, BIXIN, NORBIXIN
SynonymsCI Natural Orange 4
Definition
ClassCarotenoid
Colour Index No75120
EinecsAnnatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
Chemical names
Bixin

:

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 formula
Bixin

:

C25H30O4

Norbixin

:

C24H28O4

Molecular weight
Bixin

:

394,51

Norbixin

:

380,48

DescriptionReddish-brown powder, suspension or solution
Identification
Spectrometry
Bixin

:

maximum in chloroform at ca 502 nm

Norbixin

:

maximum 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

Bixin

:

E1 cm 1 %2 870 at ca 502 nm in chloroform

Norbixin

:

E1 cm 1 %2 870 at ca 482 nm in KOH solution

Purity
Solvent residues

Acetone

Methanol

Hexane

not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy 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

Norbixin

:

E1 cm 1 %2 870 at ca 482 nm in KOH solution

Purity
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy 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

Bixin

:

E1 cm 1 %2 870 at ca 502 nm in chloroform

Purity
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 160c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
SynonymsPaprika Oleoresin
Definition

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.

ClassCarotenoid
EinecsCapsanthin: 207-364-1, capsorubin: 207-425-2
Chemical 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 cm 1 %2 100 at ca 462 nm in acetone

DescriptionDark-red viscous liquid
Identification
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 chloroform
Purity
Solvent residues

Ethyl acetate

Methanol

Ethanol

Acetone

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
CapsaicinNot more than 250 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
[F1E 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 C 40 H 56
Molecular weight 536,85
Assay

Not less than 96 % total lycopenes (not less than 70 % all-translycopene)

E 1 cm 1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) 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) 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, 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 C 40 H 56
Molecular weight 536,85
Assay

E 1 cm 1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) 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

Propane-2-ol

Hexane

Acetone

Ethanol

Methanol

Ethylacetate

Not more than 50 mg/kg, singly or in combination

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) 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. Isopropanol 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 C 40 H 56
Molecular weight 536,85
Assay

Not less than 95 % total lycopenes and not less than 90 % all-translycopene of all colouring matters

E 1 cm 1 % at 465 - 475 nm in hexane (for 100 % pure all-translycopene) 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 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.
ClassCarotinoid
Colour Index No40820
Einecs214-171-6
Chemical namesβ-apo-8′-carotenal, Trans-β-apo-8′carotene-aldehyde
Chemical formulaC30H40O
Molecular weight416,65
Assay

Not less than 96 % of total colouring matters

E1 cm 1 %2 640 at ca 460-462 nm in cyclohexane

DescriptionDark violet crystals with metallic lustre or crystalline powder
Identification
SpectrometryMaximum in cyclohexane at 460-462 nm
Purity
Sulfated 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 160f ETHYL ESTER OF BETA-APO-8′-CAROTENOIC ACID (C30)
SynonymsCI Food Orange 7, β-apo-8′-carotenoic ester
DefinitionThese 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.
ClassCarotenoid
Colour Index No40825
Einecs214-173-7
Chemical namesβ-apo-8′-carotenoic acid ethyl ester, ethyl 8′-apo-β-caroten-8′-oate
Chemical formulaC32H44O2
Molecular weight460,7
Assay

Not less than 96 % of total colouring matters

E1 cm 1 %2 550 at ca 449 nm in cyclohexane

DescriptionRed to violet-red crystals or crystalline powder
Identification
SpectrometryMaximum in cyclohexane at ca 449 nm
Purity
Sulfated 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 matters
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 161b LUTEIN
SynonymsMixed Carotenoids, Xanthophylls
Definition

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

ClassCarotenoid
Einecs204-840-0
Chemical names3,3′-dihydroxy-d-carotene
Chemical formulaC40H56O2
Molecular weight568,88
Assay

Content of total colouring matter not less than 4 % calculated as lutein

E1 cm 1 %2 550 at ca 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)

DescriptionDark, yellowish brown liquid
Identification
SpectrometryMaximum in chloroform/ethanol (10 + 90) at ca 445 nm
Purity
Solvent residues

Acetone

Methyl ethyl ketone

Methanol

Ethanol

Propan-2-ol

Hexane

Not more than 50 mg/kg, singly or in combination
Dichloromethane: not more than 10 mg/kg
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 161g CANTHAXANTHIN
SynonymsCI Food Orange 8
DefinitionThese 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.
ClassCarotinoid
Colour Index No40850
Einecs208-187-2
Chemical namesβ-Carotene-4,4′-dione, canthaxanthin, 4,4′-dioxo-β-carotene
Chemical formulaC40H52O2
Molecular weight564,86
Assay

Not less than 96 % of total colouring matters (expressed as canthaxanthin)

E1 cm 1 %2 200

at ca 485 nm in chloroform

at 468-472 nm in cyclohexane

at 464-467 nm in petroleum ether

DescriptionDeep 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
Sulfated ashNot more than 0,1 %
Subsidiary colouring mattersCarotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 162 BEETROOT RED, BETANIN
SynonymsBeet Red
Definition

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
Einecs231-628-5
Chemical 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-carboxylate
Chemical formulaBetanin: C24H26N2O13
Molecular weight550,48
Assay

Content of red colour (expressed as betanine) is not less than 0,4 %

E1 cm 1 %1 120 at ca 535 nm in aqueous solution at pH 5

DescriptionRed or dark red liquid, paste, powder or solid
Identification
SpectrometryMaximum in water of pH 5 at ca 535 nm
Purity
NitrateNot more than 2 g nitrate anion/g of red colour (as calculated from assay).
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 163 ANTHOCYANINS
DefinitionAnthocyanins 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.
ClassAnthocyanin
Einecs208-438-6 (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 cm 1 % 300 for the pure pigment at 515-535 nm at pH 3,0
DescriptionPurplish-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

Ethanol

Not more than 50 mg/kg, singly or in combination
Sulfur dioxideNot more than 1 000 mg/kg per percent pigment
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 170 CALCIUM CARBONATE
SynonymsCI Pigment White 18, Chalk
DefinitionCalcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
ClassInorganic
Colour Index No77220
Einecs

Calcium carbonate: 207-439-9

Limestone: 215-279-6

Chemical namesCalcium carbonate
Chemical formulaCaCO3
Molecular weight100,1
AssayContent not less than 98 % on the anhydrous basis
DescriptionWhite crystalline or amorphous, odourless and tasteless powder
Identification
SolubilityPractically 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 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 combination
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
CadmiumNot more than 1 mg/kg
E 171 TITANIUM DIOXIDE
SynonymsCI Pigment White 6
DefinitionTitanium 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.
ClassInorganic
Colour Index No77891
Einecs236-675-5
Chemical namesTitanium dioxide
Chemical formulaTiO2
Molecular weight79,88
AssayContent not less than 99 % on an alumina and silica-free basis
DescriptionWhite to slightly coloured powder
Identification
SolubilityInsoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulfuric acid.
Purity
Loss 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/kg
AntimonyNot more than 50 mg/kg by total dissolution
ArsenicNot more than 3 mg/kg by total dissolution
LeadNot more than 10 mg/kg by total dissolution
MercuryNot more than 1 mg/kg by total dissolution
ZinkNot more than 50 mg/kg by total dissolution
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

DefinitionIron 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.
ClassInorganic
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 names
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

AssayYellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
DescriptionPowder; yellow, red, brown or black in hue
Identification
Solubility

Insoluble in water and in organic solvents

Soluble in concentrated mineral acids

Purity
Water soluble matterNot more than 1,0 %By total dissolution
ArsenicNot more than 5 mg/kg
BariumNot more than 50 mg/kg
CadmiumNot more than 5 mg/kg
ChromiumNot more than 100 mg/kg
CopperNot more than 50 mg/kg
LeadNot more than 20 mg/kg
MercuryNot more than 1 mg/kg
NickelNot more than 200 mg/kg
ZincNot more than 100 mg/kg
E 173 ALUMINIUM
SynonymsCI Pigment Metal, Al
DefinitionAluminium 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 No77000
Einecs231-072-3
Chemical namesAluminium
Chemical formulaAl
Atomic weight26,98
AssayNot less than 99 % calculated as Al on an oil-free basis
DescriptionA silvery-grey powder or tiny sheets
Identification
SolubilityInsoluble in water and in organic solvents. Soluble in dilute hydrochloric acid. The resulting solution gives positive tests for aluminium.
Purity
Loss on dryingNot more than 0,5 % (105 °C, to constant weight)
ArsenicNot more than 3 mg/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg
E 174 SILVER
SynonymsArgentum, Ag
ClassInorganic
Colour Index No77820
Einecs231-131-3
Chemical namesSilver
Chemical formulaAg
Atomic weight107,87
AssayContent not less than 99,5 % Ag
DescriptionSilver-coloured powder or tiny sheets
E 175 GOLD
SynonymsPigment Metal 3, Aurum, Au
ClassInorganic
Colour Index No77480
Einecs231-165-9
Chemical namesGold
Chemical formulaAu
Atomic weight197,0
AssayContent not less than 90 % Au
DescriptionGold-coloured powder or tiny sheets
Purity
SilverNot more than 7,0 %After complete dissolution
CopperNot more than 4,0 %
E 180 LITHOLRUBINE BK
SynonymsCI Pigment Red 57, Rubinpigment, Carmine 6B
DefinitionLithol 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.
ClassMonoazo
Colour Index No15850:1
Einecs226-109-5
Chemical namesCalcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate
Chemical formulaC18H12CaN2O6S
Molecular weight424,45
Assay

Content not less than 90 % total colouring matters

E1 cm 1 % 200 at ca 442 nm in dimethylformamide

DescriptionRed powder
Identification
SpectrometryMaximum in dimethylformamide at ca 442 nm
Purity
Subsidiary 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/kg
LeadNot more than 10 mg/kg
MercuryNot more than 1 mg/kg
CadmiumNot more than 1 mg/kg
Heavy metals (as Pb)Not more than 40 mg/kg

ANNEX IIU.K.

PART AU.K.

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 BU.K.

List of time-limits for transposition into national law

(referred to in Article 2)

a

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.

b

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 transposition
95/45/EC1 July 1996a
1999/75/EC1 July 2000
2001/50/EC29 June 2002
2004/47/EC1 April 2005b
2006/33/EC10 April 2007

ANNEX IIIU.K.

Correlation table

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